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

Phase 2

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: larotaxel (XRP9881); Drug: docetaxel; Drug: trastuzumab

• Registration Number: NCT00485979
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-13
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A1	larotaxel (XRP9881)	Cohort 1: Her2-ve breast cancer
Arm A2	larotaxel (XRP9881)	Cohort 2: Her2+ve breast cancer
Arm B1	docetaxel	Cohort 1: Her2-ve breast cancer
Arm B2	docetaxel	Cohort 2: Her2+ve breast cancer
Arm A2	trastuzumab	Cohort 2: Her2+ve breast cancer
Arm B2	trastuzumab	Cohort 2: Her2+ve breast cancer

Primary Outcome Measures

Name	Time	Method
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.	treatment period

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery	treatment period
Safety and tolerability profile	treatment period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇾 Montevideo, Uruguay