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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: larotaxel (XRP9881)
* Drug: docetaxel
* Drug: trastuzumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A1<br>Cohort 1: Her2-ve breast cancer | Drug: larotaxel (XRP9881)<br>* intravenous administration<br>|
| Active Comparator: Arm B1<br>Cohort 1: Her2-ve breast cancer | Drug: docetaxel<br>* intravenous administration<br>|
| Experimental: Arm A2<br>Cohort 2: Her2+ve breast cancer | Drug: larotaxel (XRP9881)<br>* intravenous administration<br>Drug: trastuzumab<br>* intravenous administration<br>|
| Active Comparator: Arm B2<br>Cohort 2: Her2+ve breast cancer | Drug: docetaxel<br>* intravenous administration<br>Drug: trastuzumab<br>* intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. |  | treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Neoadjuvant therapy