NCT00485979
Completed
Phase 2
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 of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.
ConditionsBreast Neoplasms
Overview
- Phase
- Phase 2
- Intervention
- larotaxel (XRP9881)
- Conditions
- Breast Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Arm A1
Cohort 1: Her2-ve breast cancer
Intervention: larotaxel (XRP9881)
Arm B1
Cohort 1: Her2-ve breast cancer
Intervention: docetaxel
Arm A2
Cohort 2: Her2+ve breast cancer
Intervention: larotaxel (XRP9881)
Arm A2
Cohort 2: Her2+ve breast cancer
Intervention: trastuzumab
Arm B2
Cohort 2: Her2+ve breast cancer
Intervention: docetaxel
Arm B2
Cohort 2: Her2+ve breast cancer
Intervention: trastuzumab
Outcomes
Primary Outcomes
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
Time Frame: treatment period
Secondary Outcomes
- 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)
Study Sites (1)
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