AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8Phase 3NCT06876714

ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

A Phase 3 study testing Trastuzumab (Herceptin), Pertuzumab and Echocardiography in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 702 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab (Herceptin), Pertuzumab and Echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,524 participants
Where
702 sitesin 2 countries
Study dates
17 Sep 2025to 13 Mar 2037
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)
  • Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible
  • HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer
  • Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR
  • If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts (including the requirement that at least one biopsied site on each side must have been HER2+)
  • Age ≥ 18 years
Show all 29Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively
  • Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)
  • Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped > 12 months prior to registration on this protocol
  • No use of investigational anti-cancer agents at time of registration
  • Patient must register within 14 weeks of final surgery
  • Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
  • Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed
  • Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon
  • Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible
  • Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion
  • Targeting of the regional nodal basins will be at treating investigator discretion
  • Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice
  • Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility
  • No stage IV (metastatic) breast cancer
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • No history of any prior (ipsilateral [ipsi-] or contralateral) invasive breast cancer. Prior DCIS is allowed
  • No evidence of recurrent disease following preoperative therapy and surgery
  • Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.
  • Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF < 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)
  • No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab
  • No contraindication to receipt of further HER2-directed therapy
  • No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.

Who cannot join

  • -

Trial locations and contacts

702 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jack Beranek contact

773-702-9171

breastprotocols@alliancenctn.org

304 sites in 2 countries

United States300 sites, 258 recruiting

  • UM Upper Chesapeake Hematology and Oncology - Aberdeen

    Aberdeen, Maryland, 21001

    Site Public Contact, 443-643-1029, nfadrwoski@umm.edu

    Katherine H. Tkaczuk

    Recruiting

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

    Site Public Contact, 229-312-0405, ga_cares@augusta.edu

    Anand P. Jillella

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Jacklyn M. Nemunaitis

    Recruiting

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

    Site Public Contact, 505-559-6113, WBurman@phs.org

    Jacklyn M. Nemunaitis

    Recruiting

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

    Suspended

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Suspended

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Kathleen A. Kemmer

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Demytra Mihailidis

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Suspended

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Shipra Gandhi

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Shipra Gandhi

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Shipra Gandhi

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Shipra Gandhi

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-303-3355, ClinicalTrials@northside.com

    Gena H. Volas-Redd

    Recruiting

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

    Site Public Contact, 207-626-4855

    Michael Auster

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Anna Schreiber

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • IU Health West Hospital

    Avon, Indiana, 46123

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Kathy D. Miller

    Recruiting

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Katherine H. Tkaczuk

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Site Public Contact, 443-849-3706

    Zhuoyan Li

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    Yvonne L. Ottaviano

    Recruiting

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

    Suspended

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

    Suspended

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

    Suspended

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Sigrun Hallmeyer

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Polly A. Niravath

    Recruiting

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

    Site Public Contact, 843-522-7819, kwade@bmhsc.org

    Abirami Sivapiragasam

    Recruiting

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Marija Balic

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Katherine H. Tkaczuk

    Recruiting

  • MedStar Health Bel Air Medical Campus

    Bel Air, Maryland, 21015

    Site Public Contact, David.j.perry2@medstar.net

    Ami Chitalia

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Amulya Yellala

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Suspended

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Kara K. Landry

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

    Site Public Contact, 301-319-2100

    Jeremy G. Perkins

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Karissa Britten

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    Michael Chahin

    Recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Suspended

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Suspended

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Suspended

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Adrienne G. Waks

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Suspended

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

    Site Public Contact, 800-987-3005

    Sarah J. Sinclair

    Recruiting

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Bei Jiang

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Kathleen A. Kemmer

    Recruiting

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Site Public Contact, 718-780-3677, Adg9003@nyp.org

    Evelyn O. Taiwo

    Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - Brunswick

    Brunswick, Maine, 04011

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Michael Auster

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Ellis G. Levine

    Recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

    Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org

    Maria Galkin

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Kara K. Landry

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Kara K. Landry

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Sigrun Hallmeyer

    Recruiting

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Marija Balic

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Ahmed K. Abou Hussein

    Recruiting

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Sunitha Vemulapalli

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Suspended

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Suspended

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Marija Balic

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Kathy D. Miller

    Recruiting

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org

    Shahzad Siddique

    Recruiting

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Site Public Contact, 515-689-7658, sbenson@iora.org

    Seema Harichand-Herdt

    Recruiting

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Neha Verma

    Recruiting

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

    Suspended

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Suspended

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 717-217-6020

    Marianne Spengler

    Recruiting

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Jeffrey D. Aldrich

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Abirami Sivapiragasam

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kimberly S. Strickland

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Steven A. Manobianco

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Regina M. Stein

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Site Public Contact, 312-864-5204

    Deimante M. Tamkus

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Ruta D. Rao

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Kent F. Hoskins

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Olwen M. Hahn

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Sigrun Hallmeyer

    Recruiting

  • Enloe Medical Center

    Chico, California, 95926

    Site Public Contact, 530-332-4700

    Helen K. Chew

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Kerri McGovern

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Suspended

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Suspended

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Suspended

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Alaina J. Kessler

    Recruiting

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Site Public Contact, 855-314-8646

    Yasmeen Hashimie

    Recruiting

  • Novant Health Colon and Rectal Clinic

    Clemmons, North Carolina, 27012

    Suspended

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735

    Site Public Contact, 301-877-4673

    Ami Chitalia

    Recruiting

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Suspended

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Elizabeth John

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Suspended

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Suspended

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Anna Schreiber

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Anna Schreiber

    Recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

    Suspended

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Elizabeth John

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Ashley P. Davenport

    Recruiting

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

    Site Public Contact, 603-224-2556

    Jonathan Pirruccello

    Recruiting

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Mariana Chavez Mac Gregor

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    Recruiting

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Suspended

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

    Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org

    Melanie Sheen

    Recruiting

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Marija Balic

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Alaina J. Kessler

    Recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Pratima Chalasani

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Olwen M. Hahn

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Sigrun Hallmeyer

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Sigrun Hallmeyer

    Recruiting

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

    Site Public Contact, 240-964-1400

    Marija Balic

    Recruiting

  • Houston Methodist Cypress Hospital

    Cypress, Texas, 77429

    Site Public Contact, 346-356-1413, irb@houstonmethodist.org

    Polly A. Niravath

    Recruiting

  • MaineHealth LincolnHealth Hospital

    Damariscotta, Maine, 04543

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Michael Auster

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Pratima Chalasani

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Jennifer R. Collins

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Shipra Gandhi

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Regina M. Stein

    Recruiting

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

    Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org

    Matthew J. Eadens

    Recruiting

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Anna Schreiber

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Jennifer R. Collins

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Frances Valdes-Albini

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Sigrun Hallmeyer

    Recruiting

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Alice T. Kengla

    Recruiting

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

    Site Public Contact, 404-303-3355, Clinical.trials@northside.com

    Gena H. Volas-Redd

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

    Suspended

  • Mercy Medical Center

    Durango, Colorado, 81301

    Suspended

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Neha Verma

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Pratima Chalasani

    Recruiting

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

    Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu

    Katherine H. Tkaczuk

    Recruiting

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 855-776-0015

    Saranya Chumsri

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Suspended

  • Shaw Cancer Center

    Edwards, Colorado, 81632

    Site Public Contact, 970-569-7429

    Alexander T. Urquhart

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Pratima Chalasani

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Sigrun Hallmeyer

    Recruiting

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

    Suspended

  • Stanford Cancer Center Emeryville

    Emeryville, California, 94608

    Site Public Contact, 650-498-7061, cancertrialsinfo@stanford.edu

    Amina Chaudhry

    Recruiting

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

    Site Public Contact, 201-894-3456

    Jill S. Morrison

    Recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Marianne Spengler

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Marija Balic

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Site Public Contact, 814-452-5000

    Joseph R. Liput

    Recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Farmington Health Center

    Farmington, Utah, 84025

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Jairam Krishnamurthy

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Marija Balic

    Recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • The New York Hospital Medical Center of Queens

    Flushing, New York, 11355

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Lauren Elreda

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Anna Schreiber

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Anna Schreiber

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-282-2921, trials@missioncancer.com

    Seema Harichand-Herdt

    Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Suspended

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • FMH James M Stockman Cancer Institute

    Frederick, Maryland, 21702

    Site Public Contact, 301-668-7043

    Natalia Marina

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Alice T. Kengla

    Recruiting

  • Washington Health

    Fremont, California, 94538

    Site Public Contact, 510-248-1600

    Bogdan S. Eftimie

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Alice T. Kengla

    Recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Suspended

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Suspended

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Regina M. Stein

    Recruiting

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

    Site Public Contact, 843-545-5600, broe@tidelandshealth.org

    Abirami Sivapiragasam

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Sigrun Hallmeyer

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Site Public Contact, 877-441-7957

    Marianne Spengler

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Site Public Contact, 410-553-8100

    Katherine H. Tkaczuk

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Regina M. Stein

    Recruiting

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Sigrun Hallmeyer

    Recruiting

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

    Suspended

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Elie G. Dib

    Recruiting

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

    Site Public Contact, 541-472-7000

    Alison D. Savage

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Regina M. Stein

    Recruiting

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Suspended

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Anna Schreiber

    Recruiting

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-435-8326

    Srinandan Guntupalli

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Sigrun Hallmeyer

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Meekoo Dhar

    Recruiting

  • Novant Health Breast Surgery - Greensboro

    Greensboro, North Carolina, 27403

    Suspended

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Marija Balic

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Jhansi L. Koduri

    Recruiting

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Elizabeth John

    Recruiting

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

    Site Public Contact, 503-413-2150

    Mei Dong

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 551-996-2897

    Deena M. Graham

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

    Site Public Contact, 717-632-1559

    Marianne Spengler

    Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Marija Balic

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Jing Du

    Recruiting

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

    Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org

    Ivy Abraham

    Recruiting

  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

    Suspended

  • HaysMed

    Hays, Kansas, 67601

    Site Public Contact, 785-623-5774

    Yiduo Hu

    Recruiting

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Sigrun Hallmeyer

    Recruiting

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 570-459-2901, cancerresearch@geisinger.edu

    Jennifer R. Collins

    Recruiting

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

    Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu

    John K. Hill

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Cristina I. Truica

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Anna Schreiber

    Recruiting

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    Michael Chahin

    Recruiting

  • UChicago Medicine AdventHealth Cancer Institute Hinsdale

    Hinsdale, Illinois, 60521

    Site Public Contact, cancerclinicaltrials@bsd.uchicago.edu

    Olwen M. Hahn

    Recruiting

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Pratima Chalasani

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Pratima Chalasani

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    Hollywood, Florida, 33021

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    Recruiting

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

    Site Public Contact, 808-432-5195, shelley.a.clark@kp.org

    Alice T. Kengla

    Recruiting

  • Providence Hood River Memorial Hospital

    Hood River, Oregon, 97031

    Suspended

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

    Site Public Contact, 713-566-5000

    Mariana Chavez Mac Gregor

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-790-2700

    Polly A. Niravath

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Mariana Chavez Mac Gregor

    Recruiting

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Polly A. Niravath

    Recruiting

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Mariana Chavez Mac Gregor

    Recruiting

  • Houston Methodist West Hospital

    Houston, Texas, 77094

    Site Public Contact, 832-522-2873

    Polly A. Niravath

    Recruiting

  • Novant Health Cancer Institute - Huntersville

    Huntersville, North Carolina, 28078

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kimberly S. Strickland

    Recruiting

  • Novant Health Presbyterian Medical Center Huntersville

    Huntersville, North Carolina, 28078

    Suspended

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • Saint Mary's Medical Center

    Huntington, West Virginia, 25702

    Site Public Contact, 304-526-1349

    Arvinder S. Bir

    Recruiting

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Marija Balic

    Recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Kathy D. Miller

    Recruiting

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Pratima Chalasani

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Mariana Pilon Capella

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Sayeh M. Lavasani

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Suspended

  • Allegiance Health

    Jackson, Michigan, 49201

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Saranya Chumsri

    Recruiting

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

    Site Public Contact, 910-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Suspended

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Joseph R. Liput

    Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu

    Shipra Gandhi

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Kim L. Dittus

    Recruiting

Other trials in United States

Puerto Rico4 sites, 4 recruiting

  • Doctors Cancer Center

    Manati, 00674

    Site Public Contact, 787-621-4397

    Luis J. Santos Reyes

    Recruiting

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Luis J. Santos Reyes

    Recruiting

  • PROncology

    San Juan, 00927

    Site Public Contact, 787-919-7919, info@PRoncology.com

    Luis J. Santos Reyes

    Recruiting

  • San Juan City Hospital

    San Juan, 00936

    Site Public Contact, 787-763-1296

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

About this study

Official title: ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients With Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy With HER2 Blockade

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

  1. To evaluate whether 6 months of combined neoadjuvant (neo)/adjuvant HER2 blockade results in a non-inferior recurrence-free survival (RFS) compared to 12 months of combined neo/adjuvant HER2 blockade, in patients with early stage HER2+ breast cancer who achieve pCR after neoadjuvant chemotherapy with HER2 blockade.

II. To compare the Functional Assessment of Cancer Therapy-Breast (FACT-B) total score at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life)

SECONDARY OBJECTIVES:

  1. Secondary objectives are to evaluate whether 6 months compared to 12 months results in differences for the following:

Ia. Grade 3 or higher adverse event (AE) rates; Ib. Overall survival (OS); Ic. Locoregional recurrence (LRR, both isolated LRR as first events, and LRR events simultaneous with distant metastasis [DM]) incidence; Id. RFS for key subgroups: baseline stage, hormone receptor (HR) status, neoadjuvant chemotherapy backbone, and dual versus single HER2 blockade in the adjuvant setting; Ie. Time to central nervous system (CNS) recurrence (both isolated CNS recurrence as first events, and CNS recurrence events simultaneous with distant metastasis and/or LRR).

II. To compare the FACT-B total score at 18 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) III. To compare side effect bother as measured by the Functional Assessment of Cancer Therapy General Population 5 (FACT GP5) item at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life) IV. To compare specific patient-reported symptomatic adverse events (i.e. diarrhea, constipation, fatigue, and rash) as measured by the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life)

QUALITY OF LIFE EXPLORATORY OBJECTIVES:

  1. To examine the different FACT-B subscales at all other evaluable time points.

II. To examine heterogeneity of treatment effects within subgroups defined by subcutaneous versus intravenous treatment delivery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive trastuzumab intravenously (IV) or subcutaneously (SC) on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) or multigated acquisition (MUGA) as well as mammography, ultrasound, or magnetic resonance imaging (MRI) throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

ARM 2: Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

After completion of study treatment, patients are followed up every 6 months for 5 years after registration or until recurrence and then annually for a total of 10 years after registration.

Being tested
Trastuzumab (Herceptin), Pertuzumab, Echocardiography, Multigated Acquisition Scan, Mammography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab (Herceptin)Biological

    Given IV or SC

  • PertuzumabBiological

    Given IV or SC

  • EchocardiographyProcedure or surgery

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Undergo MUGA

  • MammographyProcedure or surgery

    Undergo mammography

  • UltrasoundProcedure or surgery

    Undergo ultrasound

  • Magnetic Resonance ImagingProcedure or surgery

    Undergo MRI

  • Biospecimen CollectionProcedure or surgery

    Undergo blood and tissue sample collection

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06876714
Study groupRoleWhat they receive
Arm 1 (12-month adjuvant therapy)Active comparatorPatients receive trastuzumab IV or trastuzumab/hyaluronidase-oysk SC on day 1 of each cycle. Patients may also receive pertuzumab IV or hyaluronidase-zzxf/pertuzumab/trastuzumab SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.
Receives: Biological: Trastuzumab (Herceptin); Biological: Pertuzumab; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Mammography; Procedure: Ultrasound; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration
Arm 2 (6-month adjuvant therapy)ExperimentalPatients receive trastuzumab IV or trastuzumab/hyaluronidase-oysk SC on day 1 of each cycle. Patients may also receive pertuzumab IV or hyaluronidase-zzxf/pertuzumab/trastuzumab SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.
Receives: Biological: Trastuzumab (Herceptin); Biological: Pertuzumab; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Mammography; Procedure: Ultrasound; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free survival (RFS)

    The Kaplan-Meier method will be used to estimate the distribution of RFS times and a stratified log-rank test for non-inferiority will be used to assess whether RFS with 6 total months of human epidermal growth factor receptor 2 (HER2)-blockade is non-inferior to standard-of-care 12 total months of HER2-blockade in this patient population. Stratified Cox modeling will be used to estimate the hazard ratio and corresponding one-sided 95% confidence interval (CI).

    Measured: From randomization to invasive local, regional or distant breast cancer recurrence, or death from any cause prior to a documented disease recurrence, assessed up to 10 years

  2. Functional Assessment of Cancer Therapy-Breast (FACT-B) total score (Quality of life)

    Will compare the FACT-B total score between patients randomized to receive 6 months versus 12 months of combined neoadjuvant/adjuvant HER2 blockade. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. An intention-to-treat (ITT) approach will be used for all analyses. All statistical tests will be 2-sided, and p-values < 0.05 will be considered statistically significant. To evaluate the between-arm mean difference in scores, a repeated measures mixed model will be estimated based on FACT-B total scores at all time points.

    Measured: At 12 months

Secondary outcomes (8)

  1. Incidence of grade 3 or higher adverse events (AE)

    Will be according to the Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of a specific AE experienced by a patient will be used. The proportion of patients who report a grade 3 or higher AE will be compared between the two treatment arms with a chi-square test. AEs (type and grade) for both arms will be summarized with the frequency and relative frequency

    Measured: Baseline to 30 days after last dose of study treatment

  2. Locoregional recurrence (LRR)

    The cumulative incidence of LRR will be analyzed with Kaplan-Meier estimates (curve starting at 0 rather than 1) and compared with a stratified log rank test.

    Measured: From randomization until invasive tumor recurs in the ipsilateral breast or chest wall, axillary, supraclavicular, or internal mammary nodes (if before or synchronous with a systemic recurrence), whichever comes first, assessed up to 10 years

  3. Overall survival

    Will be compared between the treatment arms with a stratified log rank test and a stratified Cox model will be used to generate the hazard ratio estimate (both a point estimate and 95% CI). The analyses will be done as ITT groups as well as per-protocol groups.

    Measured: From randomization until death due to any cause, assessed up to 10 years

  4. RFS for key subgroups

    Forest plots will be generated for key prognostic variables (including the stratification variables) and subgroups of interest to determine whether the treatment effect appears homogeneous across the subgroups for the ITT population. Additional key subgroups of interest are neoadjuvant chemotherapy backbone and the type of adjuvant HER2-blockade the patient actually received (dual versus single). With respect to the latter analysis, the interest will be in whether there is an apparent difference in treatment effect among patients who received adjuvant pertuzumab versus those who did not.

    Measured: From randomization to invasive local, regional or distant breast cancer recurrence, or death from any cause prior to a documented disease recurrence, assessed up to 10 years

  5. Time to central nervous system (CNS) recurrence

    Will assess both isolated CNS recurrence as first events, and CNS recurrence events simultaneous with distant metastasis and/or LRR.

    Measured: up to 10 years

  6. FACT-B total score (Quality of life)

    Will compare the FACT-B total score between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. An ITT approach will be used for all analyses. All statistical tests will be 2-sided, and p-values <0.05 will be considered statistically significant. To evaluate the between-arm mean difference in scores, a repeated measures mixed model will be estimated based on FACT-B total scores at all time points.

    Measured: At 18 months

  7. Side effect bother (Quality of life)

    Will be assessed by Functional Assessment of Cancer Therapy General Population 5 between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. An ITT approach will be used for all analyses. All statistical tests will be 2-sided, and p-values <0.05 will be considered statistically significant. To evaluate the between-arm mean difference in scores, a repeated measures mixed model will be estimated based on scores. Mean trajectories over time will be plotted by arm.

    Measured: At 6 or 12 months

  8. Patient reported symptomatic AE (Quality of life)

    Will be measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Will assess symptomatic AE using PRO-CTCAE measures for symptoms of interest, specifically diarrhea, constipation, fatigue, and rash. The proportion of patients with a maximum post-baseline score greater than 0 will be compared between arms using Fisher's exact test. For diarrhea, constipation, and fatigue, the proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared between arms using Fisher's exact test.

    Measured: At 6 or 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start17 Sep 2025
  3. Primary completion13 Mar 2028 (estimated)
  4. Study completion13 Mar 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,524 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06876714
Sponsor's protocol ID
A012303
Other IDs
NCI-2024-10478
Status last verified
Sep 2026
First submitted
10 Mar 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab (Herceptin), Pertuzumab and Echocardiography in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 702 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 702 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jack Beranek (773-702-9171, breastprotocols@alliancenctn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival (RFS) (time frame: From randomization to invasive local, regional or distant breast cancer recurrence, or death from any cause prior to a documented disease recurrence, assessed up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06876714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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