Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-Cyclophosphamide in Breast Cancer Patients - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00485979

Purpose

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	Intervention	Phase
Breast Neoplasms	Drug: larotaxel (XRP9881) Drug: docetaxel Drug: trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Docetaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. [ Time Frame: treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Safety and tolerability profile [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	310
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A1: Experimental Cohort 1: Her2-ve breast cancer	Drug: larotaxel (XRP9881) intravenous administration
Arm B1: Active Comparator Cohort 1: Her2-ve breast cancer	Drug: docetaxel intravenous administration
Arm A2: Experimental Cohort 2: Her2+ve breast cancer	Drug: larotaxel (XRP9881) intravenous administration Drug: trastuzumab intravenous administration
Arm B2: Active Comparator Cohort 2: Her2+ve breast cancer	Drug: docetaxel intravenous administration Drug: trastuzumab intravenous administration

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485979

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

Belgium
Sanofi-Aventis Administrative Office	Recruiting
Diegem, Belgium
Contact GV-Contact-us@sanofi-aventis.com
Brazil
Sanofi-Aventis Administrative Office	Recruiting
Sao Paulo, Brazil
Contact GV-Contact-us@sanofi-aventis.com
France
Sanofi-Aventis Administrative Office	Recruiting
Paris, France
Contact GV-Contact-us@sanofi-aventis.com
Germany
Sanofi-Aventis Administrative Office	Recruiting
Berlin, Germany
Contact GV-Contact-us@sanofi-aventis.com
Poland
Sanofi-Aventis Administrative Office	Recruiting
Warszawa, Poland
Contact GV-Contact-us@sanofi-aventis.com
Tunisia
Sanofi-Aventis Administrative Office	Recruiting
Megrine, Tunisia
Contact GV-Contact-us@sanofi-aventis.com
United Kingdom
Sanofi-Aventis Administrative Office	Recruiting
Guildford, United Kingdom
Contact GV-Contact-us@sanofi-aventis.com
Uruguay
Sanofi-Aventis Administrative Office	Recruiting
Montevideo, Uruguay
Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Michel Marty, MD

Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10073, EudraCT 2006-006473-24
Study First Received:	June 12, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00485979
Health Authority:	France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Sanofi-Aventis:

Breast Cancer
Neoadjuvant therapy

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab

Breast Neoplasms
Cyclophosphamide
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009