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.
OBJECTIVES: Primary * To determine if the docetaxel and cyclophosphamide (TC) regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (DFS) by combining B-49 data with the docetaxel, doxorubicin, and cyclophosphamide (TAC) and TC arms of NSABP B-46-I/US Oncology Research, Inc.(USOR) 07132 and the data from USOR 06-090. Secondary * To determine rates of DFS-ductal carcinoma in situ (DCIS) for the TC and anthracycline-based chemotherapy regimens. * To determine rates of overall survival (OS) for the TC and anthracycline-based chemotherapy regimens. * To determine rates of recurrence-free interval (RFI) for the TC and anthracycline-based chemotherapy regimens. * To evaluate the toxicity associated with each of the regimens. * To determine the role of TOP2A in prognosis and prediction of degree of benefit from anthracycline-based chemotherapy over TC. (exploratory) * To develop predictive markers for benefit from doxorubicin. (exploratory) OUTLINE: This is a multicenter randomized study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs 4-9 vs 10+) and hormone-receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive vs ER and PgR negative). Patients are randomized to 1 of 2 treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,871
Providence Alaska Medical Center
Anchorage, Alaska, United States
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
Invasive disease-free survival (IDFS)
The time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Disease-free survival (DFS-DCIS)
The time to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Overall survival (OS)
Time from randomization until death from any cause.
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Recurrence-free interval (RFI)
Time from randomization until local, regional, or distant recurrence.
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Toxicity of each regimen
Frequencies of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Molecular predictors of efficacy
To develop predictive markers for benefit from doxorubicin.
Time frame: Tissue sample collected at time of surgery
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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
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