NCT01547741

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,871 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Doxorubicin
DRUG	Cyclophosphamide
DRUG	Docetaxel
DRUG	Paclitaxel

Timeline

• Start date: 2012-04-01
• Primary completion: 2022-05-01
• Completion: 2023-11-01
• First posted: 2012-03-08
• Last updated: 2022-04-14

Locations

915 sites across 2 countries: United States, Puerto Rico