Trial intelligence / Profile preview

Docetaxel and letrozole in hormone receptor-positive breast cancer

NCT00617968Phase 2

Key facts

Status: Completed
Start: Oct 2003
Countries: 1
Sponsor: Sanofi
Modality: Small Molecules

Drugs: docetaxel
Conditions: breast cancer

Overview

Phase 2, randomised, open-label trial of docetaxel in breast cancer (2 arms), sponsored by Sanofi. Primary endpoint: Rate of clinical and radiological response evaluated according to RECIST criteria. Started Oct 2003; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Docetaxel + Letrozole
Neoadjuvant treatment with a combination of Docetaxel and Letrozole.
Letrozole
Neoadjuvant treatment with Letrozole alone.

Who it enrols

Postmenopausal women aged 60 or older with operable, non-metastatic, unilateral, grade I/II, T2-T3 breast cancer. Tumors must be >2cm, hormone receptor-positive (ER+ and/or PR+), and HER2 negative or low (0, 1+, or 2+).

Endpoints

Primary

Rate of clinical and radiological response evaluated according to RECIST criteriaDuring the study conduct

Secondary

Rate of histological responseDuring the study conduct

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