A randomized, open-label, multi-center study of larotaxel at 90mg/m² or docetaxel every 3 weeks, alone or in combination with trastuzumab according to Her2neu status, administered after a combination regimen of anthracycline and cyclophosphamide as pre-operative therapy in patients with high risk localized breast cancer - SATI

• Conditions: high risk localized breast cancer; MedDRA version: 8.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-006473-24-DE
• Lead Sponsor: sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-22
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

1. For enrollment (before run-in treatment):
-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 > or = 3 cm (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).
* Known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)

2. For randomization (at the end of run-in treatment):
-Hormonal receptors, cytokeratin 5/6 and /or cytokeratin 17, p53 and Ki67 by IHC
-Patients having received at least 3 cycles of anthracycline and cyclophosphamide
-Patients with no disease progression.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. For enrollment (before run-in treatment):
- Abnormal LVEF (< 50%)
- Prior or current history and study drugs-linked criteria:
*Bilateral breast cancer
* Multifocal breast tumors
*Inflammatory breast cancer
*Distant metastases (stage IV)
*Loco-regional relapse
*Any of the following within 6 months prior to enrollment: myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4)

2.For randomization (at the end of run-in treatment):
-Abnormal LVEF (< 50%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).;Secondary Objective: To assess the:<br>- clinical Response Rate (RR)<br>- rate of breast conservation<br>- Progression-Free Survival (PFS)<br>- Overall Survival (OS)<br>- safety and tolerability profile.<br>- pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria<br><br>To rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.;Primary end point(s): pathological Complete Response (pCR) rate (according to Chevallier criteria)