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A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
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
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
Start Date
April 1, 2012
Primary Completion Date
May 1, 2022
Completion Date
November 1, 2023
Last Updated
April 14, 2022
1,871
ACTUAL participants
Doxorubicin
DRUG
Cyclophosphamide
DRUG
Docetaxel
DRUG
Paclitaxel
DRUG
Lead Sponsor
NSABP Foundation Inc
Collaborators
NCT05372640
NCT04704661
Data Source & Attribution
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