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

NCT00485979 | Completed Phase 2

• 2 other identifiers: EFC10073EudraCT 2006-006473-24
• Study Type: interventional
• Target: 330
• Locations: 8 countries
• Sites: 8

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.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.

  treatment period

Secondary Outcomes (2)

• 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

• Safety and tolerability profile

  treatment period

Study Arms (4)

Arm A1

EXPERIMENTAL

Cohort 1: Her2-ve breast cancer

Drug: larotaxel (XRP9881)

Arm B1

ACTIVE COMPARATOR

Cohort 1: Her2-ve breast cancer

Drug: docetaxel

Arm A2

EXPERIMENTAL

Cohort 2: Her2+ve breast cancer

Drug: larotaxel (XRP9881); Drug: trastuzumab

Arm B2

ACTIVE COMPARATOR

Cohort 2: Her2+ve breast cancer

Drug: docetaxel; Drug: trastuzumab

Interventions

larotaxel (XRP9881) DRUG

intravenous administration

Arm A1; Arm A2

docetaxel DRUG

intravenous administration

Arm B1; Arm B2

trastuzumab DRUG

intravenous administration

Arm A2; Arm B2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Sanofi-Aventis Administrative Office

Warsaw, Poland

Location

Sanofi-Aventis Administrative Office

Mégrine, Tunisia

Location

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Location

Sanofi-Aventis Administrative Office

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

larotaxel; Docetaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michel Marty, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

TU (1); UR (1); BE (1); BR (1); FR (1); DE (1); GB (1); PL (1)