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

June 27, 2011 updated by: Sanofi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diegem, Belgium
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Poland
      • Warszawa, Poland
        • Sanofi-Aventis Administrative Office
  • Tunisia
      • Megrine, Tunisia
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis Administrative Office
  • Uruguay
      • Montevideo, Uruguay
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: treatment period
treatment period
Safety and tolerability profile
Time Frame: treatment period
treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Michel Marty, MD, Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 12, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10073
  • EudraCT 2006-006473-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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