high risk localized breast cancer MedDRA version: 8.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: Larotaxel
Product Code: XRP9881
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Larotaxel
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 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). - As of June 30, 2008, known status for Her2neu by immunohistochemistry (ICH) or by fluorescent in situ hybridisation (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
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%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).; Secondary Objective: To assess the: - clinical Response Rate (RR) - rate of breast conservation - Progression-Free Survival (PFS) - Overall Survival (OS) - safety and tolerability profile. - 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. ;Primary end point(s): pathological Complete Response (pCR) rate (according to Chevallier criteria) | — |
Countries
Belgium, France, Germany, United Kingdom
Outcome results
None listed