Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).

The secondary objectives are:

• to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,

• to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cyclophosphamide; Docetaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically proven invasive breast adenocarcinoma

• Localized breast cancer: stage II and III

• Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate)

• After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)

Exclusion Criteria:

• Bilateral and inflammatory breast cancer

• Abnormal Left Ventricular Ejection Fraction

• Distant metastases or locoregional relapse

• Inadequate organ functions

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.