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.
18 Years
75 Years
Female
Breast Neoplasms
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
Outcome Time Frame:
treatment period
Safety Issue:
No
Principal Investigator
Michel Marty, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
EFC10073
NCT ID:
NCT00485979
Start Date:
June 2007
Completion Date:
August 2010
Related Keywords:
- Breast Neoplasms
- Breast Cancer
- Neoadjuvant therapy
- Breast Neoplasms
- Neoplasms
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