Trial intelligence / Profile preview

Adjuvant Docetaxel Regimens in Node-Positive HER2-Negative Breast Cancer

NCT00312208Phase 3

Key facts

Status: Completed
Start: Nov 2001
Primary completion: Oct 2008
Countries: 37
Sponsor: Sanofi
Modality: Small Molecules

Drugs: docetaxel
Conditions: breast cancer

Overview

Phase 3, randomised, open-label trial of docetaxel in breast cancer (2 arms), sponsored by Sanofi. Primary endpoint: Disease-Free Survival at 65 months. Started Nov 2001; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

AC -> T
Doxorubicin + Cyclophosphamide x 4 cycles followed by Docetaxel x 4 cycles
TAC
Docetaxel + Doxorubicin + Cyclophosphamide x 6 cycles

Who it enrols

Women with operable, node-positive, HER2-negative invasive breast adenocarcinoma who have undergone definitive surgery.

Endpoints

Primary

Disease-Free Survival65 months

Secondary

Overall Survival65 months
Toxicity
Quality of Life

Results

Not all primary endpoints met

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