Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

Key facts

Study ID

NCT01547741

Run by

NSABP Foundation Inc

People needed

4242

Starts

2012-04-01

Expected to finish

2025-10-17

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
• The breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative based on current American Society of Clinical Oncology (ASCO)/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ hybridization [CISH], or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy.
• All of the following staging criteria must be met according to American Joint Committee on Cancer (AJCC) criteria:
• By pathologic evaluation, primary tumor must be pT1-3;
• By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
• If pN0, at least one of the following criteria must be met:
• ER negative and PgR negative; or
• Pathologic tumor size greater than 2.0 cm; or
• T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of greater than or equal to 25.
• Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy).
• For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
• For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS.
• Patients must have completed one of the following procedures for evaluation of pathologic nodal status:
• Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b;
• Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN1a limited to 1 or 2 positive nodes and primary tumor is T1 or T2 by pathologic evaluation;
• Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
• Axillary lymphadenectomy with or without SN isolation procedure.
• The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days.
• Patients must have ER analysis performed on the primary tumor prior to randomization. Breast cancer must be assessed for ER status by current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. (Either a core biopsy or surgical resection specimen can be used for ER/PgR testing.)
• The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria:
• absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3;
• platelet count must be greater than or equal to 100,000/mm3; and
• hemoglobin must be greater than or equal to 10 g/dL.
• The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization:

You may not qualify if…

• Patients with one or more of the following conditions are ineligible for this study.
• T4 tumors including inflammatory breast cancer.
• Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)
• Synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS are eligible.)
• Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.
• History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
• Previous therapy with anthracyclines or taxanes for any malignancy.
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization.
• Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. Patients are eligible if these medications are discontinued prior to randomization.
• Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.
• Known active hepatitis B or hepatitis C with abnormal liver function tests.
• Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
• Active cardiac disease
• angina pectoris that requires the use of anti-anginal medication;
• ventricular arrhythmias except for benign premature ventricular contractions;
• supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
• conduction abnormality requiring a pacemaker;
• valvular disease with documented compromise in cardiac function;
• symptomatic pericarditis.
• History of cardiac disease
• myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function;
• history of documented congestive heart failure (CHF);
• documented cardiomyopathy.
• Whole breast radiation therapy (RT) prior to randomization or partial breast RT that cannot be completed on or before the date of randomization.
• Intrinsic lung disease resulting in dyspnea.

Where it is running

• Arizona Oncology Associates-Biltmore Cancer Center — Phoenix, Arizona, United States
• Premiere Oncology of Arizona — Scottsdale, Arizona, United States
• Sedona Medical Center — Sedona, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• NEA Baptist Clinic-Matthews — Jonesboro, Arkansas, United States
• Kaiser Anaheim Medical Center — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Kaiser Permanente Medical Group - Baldwin Park — Baldwin Park, California, United States
• Kaiser Foundation Hospital — Bellflower, California, United States
• Providence Saint Joseph Medical Center — Burbank, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Northbay Cancer Center — Fairfield, California, United States
• Kaiser Permanente Hospital — Fontana, California, United States
• Kaiser Permanente, Fremont — Fremont, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Washington Hospital — Fremont, California, United States
• California Cancer Center - North Fresno — Fresno, California, United States
• Kaiser Permanente — Fresno, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente, Hayward — Hayward, California, United States
• Southern California Permanente Medical Group — Irvine, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.