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

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Docetaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]


Enrollment:	330
Study Start Date:	June 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

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, see Learn About Clinical Studies.

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

Locations


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


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

More Information


Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00485979 History of Changes
Other Study ID Numbers:	EFC10073 EudraCT 2006-006473-24
Study First Received:	June 12, 2007
Last Updated:	June 27, 2011
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

Keywords provided by Sanofi:


Breast Cancer Neoadjuvant therapy

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Trastuzumab Immunosuppressive Agents Immunologic Factors	Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators

ClinicalTrials.gov processed this record on September 27, 2016

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