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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00485979
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Sanofi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: larotaxel (XRP9881) Drug: docetaxel Drug: trastuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : June 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. [ Time Frame: treatment period ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety and tolerability profile [ Time Frame: treatment period ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485979


Locations
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Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Uruguay
Sanofi-Aventis Administrative Office
Montevideo, Uruguay
Sponsors and Collaborators
Sanofi
Investigators
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Principal Investigator: Michel Marty, MD Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital
More Information
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Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00485979    
Other Study ID Numbers: EFC10073
EudraCT 2006-006473-24
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011
Keywords provided by Sanofi:
Breast Cancer
Neoadjuvant therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological