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Breast CancerPhase 2NCT00493649

Adj TC + Herceptin Early Stage Breast Cancer

A Phase 2 study testing Taxotere, Cytoxan and Herceptin in people with Breast Cancer, run by US Oncology Research at 69 sites in United States.

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

The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Taxotere, Cytoxan and Herceptin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
69 sitesUnited States
Study dates
Jun 2007to Apr 2013
Phase
Phase 2
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A woman will be eligible for inclusion in this study if she meets all of the following criteria:
  • Has HER2+ (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.
  • Has operable, histologically confirmed, invasive carcinoma of the breast.
  • Has known ER and PR status
  • Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)
  • Has had no prior chemotherapy unless it was given >5 years ago for breast cancer or other cancer
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  • Has an ECOG Performance Status (PS) 0-1
  • Age >18 to <70 years old.
  • Has laboratory values of: See protocol for specific details
  • Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
  • Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.
  • It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician
  • Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.
  • Has normal cardiac function as evidenced by a LVEF >50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.
  • Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause]).
  • If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Who cannot join

  • A woman will be excluded from this study if she meets any of the following criteria:
  • Has any evidence of disease following complete surgical resection of the primary tumor and metastatic workup
  • Has Stage IIIB breast cancer (T4 disease; ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
  • Has Stage IV breast cancer (M1 disease on TNM staging system)
  • Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)
  • Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
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  • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes
  • Has abnormal baseline MUGA (or ECHO) (<50%, or less than institutional LLN)
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
  • Has peripheral neuropathy >Grade 1
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
  • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible
  • Is a pregnant or breastfeeding woman
  • Is deemed unable to comply with requirements of study

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Texas Cancer Center-Abilene (South)

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12006

  • Texas Oncology, P.A.-Amarillo

    Amarillo, Texas, 79106

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, P.A.-Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Hematology Oncology Associates of IL

    Chicago, Illinois, 60611

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Rose

    Denver, Colorado, 80220

  • Puget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern VA Hem-Onc PC

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Hematology-Oncology Associates of NNJ, P.A.

    Morristown, New Jersey, 07960

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Ruth Oratz MD

    New York, New York, 10016

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Texas Oncology-Odessa

    Odessa, Texas, 79761

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • Onc and Hem Associates of SW VA, Inc.

    Salem, Virginia, 24153

  • San Antonio Tumor and Blood Clinic

    San Antonio, Texas, 78217

  • HOAST-Medical Dr.

    San Antonio, Texas, 78229

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology & Oncology Associates

    Sedona, Arizona, 86336

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Arch Medical Services, Inc.

    St Louis, Missouri, 63141

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Hope Center

    Terre Haute, Indiana, 47802

  • Connecticut Oncology & Hematology, LLP

    Torrington, Connecticut, 06790

  • Arizona Oncology Associates DBA HOPE

    Tucson, Arizona, 85704

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research

    Waco, Texas, 76712

  • Texas Oncology PA

    Webster, Texas, 77598

  • Alliance Hematology Oncology P.A.

    Westminster, Maryland, 21157

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) Plus Trastuzumab in HER2-Positive Early Stage Breast Cancer Patients

The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.

Conditions
Breast Cancer
Being tested
Taxotere, Cytoxan, Herceptin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TaxotereDrug

    Also called docetaxel

    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.

  • CytoxanDrug

    Also called cyclophosphamide

    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.

  • HerceptinDrug

    Also called trastuzumab

    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.

Study groups in NCT00493649
Study groupRoleWhat they receive
TC+HExperimentalOn Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter.
Receives: Drug: Taxotere; Drug: Cytoxan; Drug: Herceptin

What is being measured

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

  1. Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.

    DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.

    Measured: 2 years

Secondary outcomes (3)

  1. Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.

    OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: 2 years

  2. DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.

    DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.

    Measured: 2 years

  3. OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.

    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: 2 years

Timeline

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

  1. First posted28 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2013
  4. Study completionApr 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493649
Sponsor's protocol ID
06-038
Other IDs
11270
Status last verified
Sep 2016
First submitted
27 Jun 2007
Last updated
3 Nov 2016
Data monitoring committee
No

Publications

  • Jones SE, Collea R, Paul D, Sedlacek S, Favret AM, Gore I Jr, Lindquist DL, Holmes FA, Allison MAK, Brooks BD, Portillo RM, Vukelja SJ, Steinberg MS, Stokoe C, Crockett MW, Wang Y, Asmar L, Robert NJ, O'Shaughnessy J. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol. 2013 Oct;14(11):1121-1128. doi: 10.1016/S1470-2045(13)70384-X. Epub 2013 Sep 3.

    PubMed 24007746

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Taxotere, Cytoxan and Herceptin in people with Breast Cancer, run by US Oncology Research at 69 sites in United States.

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 18 inclusion and 17 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Nov 2016). 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?

Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. (time frame: 2 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 NCT00493649, which also lists 1 linked publication.

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 3 Nov 2016.

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