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

Breast Neoplasms Clinical Trial

— SATIN  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485979
• Other study ID #: EFC10073
• Secondary ID: EudraCT 2006-006
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2007
• Last updated: June 27, 2011
• Start date: June 2007
• Est. completion date: August 2010

Study information

• Verified date: June 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• larotaxel (XRP9881)
intravenous administration
• docetaxel
intravenous administration
• trastuzumab
intravenous administration

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Poland	Sanofi-Aventis Administrative Office	Warszawa
Tunisia	Sanofi-Aventis Administrative Office	Megrine
United Kingdom	Sanofi-Aventis Administrative Office	Guildford
Uruguay	Sanofi-Aventis Administrative Office	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Brazil,  France,  Germany,  Poland,  Tunisia,  United Kingdom,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.		treatment period	No
Secondary	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	No
Secondary	Safety and tolerability profile		treatment period	Yes