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HER2/Neu PositivePhase 3NCT00513292

Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

A Phase 3 study testing Cyclophosphamide, Epirubicin Hydrochloride and Laboratory Biomarker Analysis in people with HER2/Neu Positive and Stage IA Breast Cancer, run by National Cancer Institute (NCI) at 115 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cyclophosphamide, Epirubicin Hydrochloride and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
115 sitesin 2 countries
Study dates
Jul 2007to 21 Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of invasive adenocarcinoma by core needle biopsy
  • Fine needle aspiration allowed provided primary tumor size < 2 cm and lymph node metastases are present
  • Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present
  • Primary tumor ≥ 2 cm and/or ≥ 1 biopsy-positive lymph node
  • HER2-positive disease
  • Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification
Show all 60Show fewer
  • Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score
  • Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed
  • Synchronous invasive breast cancer not allowed
  • Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed
  • Those treated with radiation therapy are not allowed
  • No definitive clinical or radiologic evidence of metastatic disease
  • No history of invasive breast cancer
  • Hormone receptor status known
  • Menopausal status not specified
  • ECOG performance status of 0 -1
  • Absolute neutrophil count ≥ 1,200/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal [ULN]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 1.5 times ULN
  • Creatinine normal
  • Left ventricular ejection fraction (LVEF) ≥ 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months
  • Patients with either skeletal pain or alkaline phosphatase that is > ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease
  • Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy
  • Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence
  • Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:
  • Carcinoma in situ of the cervix
  • Colon carcinoma in situ
  • Melanoma in situ
  • Basal cell and squamous cell carcinoma of the skin
  • No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:
  • Active cardiac disease
  • Angina pectoris that requires the use of antianginal medication
  • Cardiac arrhythmia requiring medication
  • Severe conduction abnormality
  • Clinically significant valvular disease
  • Cardiomegaly on chest x-ray
  • Ventricular hypertrophy on EKG
  • Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)
  • Patients with hypertension that is well controlled on medication are eligible
  • History of cardiac disease
  • Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests
  • Documented congestive heart failure
  • Documented cardiomyopathy
  • No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
  • Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration
  • Not pregnant or nursing
  • No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  • No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens
  • No prior surgical axillary staging procedure
  • Prior non-excisional biopsy of an axillary node allowed
  • No prior treatment for this breast cancer
  • Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry
  • Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery
  • No prior therapy with anthracyclines or taxanes for any malignancy
  • No other investigational agents within the past 30 days
  • No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)
  • No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention

Who cannot join

None listed.

Trial locations and contacts

115 sites in 2 countries.

115 sites in 2 countries

United States114 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Rose Hospital

    Hayward, California, 94545

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Franciscan Saint Francis Health-Indianapolis

    Indianapolis, Indiana, 46237

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67901

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Nashville Breast Center

    Nashville, Tennessee, 37203

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • UMDNJ - New Jersey Medical School

    Newark, New Jersey, 07103

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Sentara Port Warwick

    Newport News, Virginia, 23606

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066-3896

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03802

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • MidHudson Regional Hospital of Westchester Medical Center

    Poughkeepsie, New York, 12601

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Unspecified Site

    Rockville, Maryland, 20852

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer

This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.

Read the detailed description

PRIMARY OBJECTIVES:

  1. The primary objective of this study is to compare the pathologic complete response rate (pCR) within the breast of a sequential regimen of concurrent weekly paclitaxel and trastuzumab, followed by continued weekly trastuzumab administered concurrently with FEC-75 (Arm 2), to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab (Arm 1).

SECONDARY OBJECTIVES:

  1. To estimate the cardiotoxicity of a sequential regimen of concurrent weekly paclitaxel and trastuzumab, followed by continued weekly trastuzumab administered concurrently with FEC-75, followed postoperatively by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose (Arm 2), and compare the cardiotoxicity to that of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab, followed by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose (Arm 1).

II. To compare the combined pCR rate in the breast and ipsilateral axilla obtained with the two regimens evaluated in this study.

III. To compare the clinical response rates (cRR) of the two regimens evaluated in this study.

IV. To compare the non-cardiac toxicity of the two regimens evaluated in this study.

  1. To compare breast conservation rates achieved with the two regimens evaluated in this study.

VI. To evaluate disease-free survival and overall survival at 5 years post-randomization.

VII. To correlate pCR rate with potential molecular markers of response.

OUTLINE: Patients are stratified by clinical tumor size (breast tumor size < 2 cm and nodal metastases < 2 cm vs breast tumor size < 2 cm and nodal metastases ≥ 2 cm vs breast tumor size 2-4 cm [any nodal status] vs breast tumor size ≥ 4 cm [any nodal status]), age (< 50 vs ≥ 50) and hormone receptor status (estrogen receptor [ER]- and progesterone receptor [PgR]-negative vs ER- and/or PgR-positive). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive FEC comprising fluoroucacil intravenously (IV), epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks.

ARM II: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after completion of paclitaxel and trastuzumab, patients receive FEC comprising fluoroucacil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Being tested
Cyclophosphamide, Epirubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Therapeutic Conventional Surgery
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • Epirubicin HydrochlorideDrug

    Also called Ellence, IMI-28, Pharmorubicin PFS

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

  • TrastuzumabBiological

    Also called ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2

    Given IV

Study groups in NCT00513292
Study groupRoleWhat they receive
FEC-75 then Paclitaxel/trastuzumabActive comparatorPatients receive FEC comprising fluoroucacil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks.
Receives: Drug: Cyclophosphamide; Drug: Epirubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Procedure: Therapeutic Conventional Surgery; Biological: Trastuzumab
Paclitaxel/trastuzumab then trastuzumab/FEC-75ExperimentalPatients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluoroucacil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I.
Receives: Drug: Cyclophosphamide; Drug: Epirubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Procedure: Therapeutic Conventional Surgery; Biological: Trastuzumab

What is being measured

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

  1. pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy

    Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy

    pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).

    Measured: Up to 5 years

  2. Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12

    The summary of asymptomatic decrease in LVEF.

    Measured: Baseline, at 12 week

  3. Asymptomatic Decreases From Baseline in LVEF at Week 24

    The summary of asymptomatic changed in LVEF.

    Measured: Baseline, at 24 week

  4. LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week

    All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].

    Measured: At 12 week

  5. Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week

    Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].

    Measured: Baseline, at 24 week

  6. Breast Conservation

    Surgery was categorized as breast conserving surgery ("Partial Mastectomy") or non-conserving surgery ("Total Mastectomy" or "Modified Radical Mastectomy). Reported below is the percentage of patients receiving "Partial Mastectomy". This was calculated by dividing the number of patients receiving "Partial Mastectomy" by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage).

    Measured: From time surgery to up to 5 years

  7. Disease-free Survival (DFS)

    DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.

    Measured: From time to registration to time of event, assessed up to 5 years

  8. Overall Survival (OS)

    OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.

    Measured: From time to registration to death, assessed up to 5 years

Timeline

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

  1. First posted8 Aug 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJun 2012
  4. Study completion21 Feb 2013

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
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513292
Sponsor's protocol ID
NCI-2009-00341
Other IDs
NCI-2009-00341, CDR0000559039, ACOSOG-Z1041, Z1041, ACOSOG-Z1041, U10CA012027
Status last verified
Jan 2019
First submitted
6 Aug 2007
Last updated
23 Jan 2019

Publications

  • Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig GW, Royce ME, Hunt KK. Disease-Free and Overall Survival Among Patients With Operable HER2-Positive Breast Cancer Treated With Sequential vs Concurrent Chemotherapy: The ACOSOG Z1041 (Alliance) Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):45-50. doi: 10.1001/jamaoncol.2018.3691.

    PubMed 30193295

  • Lesurf R, Griffith OL, Griffith M, Hundal J, Trani L, Watson MA, Aft R, Ellis MJ, Ota D, Suman VJ, Meric-Bernstam F, Leitch AM, Boughey JC, Unzeitig G, Buzdar AU, Hunt KK, Mardis ER. Genomic characterization of HER2-positive breast cancer and response to neoadjuvant trastuzumab and chemotherapy-results from the ACOSOG Z1041 (Alliance) trial. Ann Oncol. 2017 May 1;28(5):1070-1077. doi: 10.1093/annonc/mdx048.

    PubMed 28453704

  • Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig G, Royce M, McCall LM, Ewer MS, Hunt KK; American College of Surgeons Oncology Group investigators. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1317-25. doi: 10.1016/S1470-2045(13)70502-3. Epub 2013 Nov 13.

    PubMed 24239210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Epirubicin Hydrochloride and Laboratory Biomarker Analysis in people with HER2/Neu Positive and Stage IA Breast Cancer, run by National Cancer Institute (NCI) at 115 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 60 inclusion and 0 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: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 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?

Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy (time frame: Up to 5 years). 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 NCT00513292, which also lists 3 linked publications.

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 23 Jan 2019.

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