Docetaxel & Cyclophosphamide Compared to Anthracycline-Based Chemotherapy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01547741
Study type	Interventional
Source	NSABP Foundation Inc
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	April 2012
Completion date	November 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms