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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A1

Cohort 1: Her2-ve breast cancer

Group Type EXPERIMENTAL

larotaxel (XRP9881)

Intervention Type DRUG

intravenous administration

Arm B1

Cohort 1: Her2-ve breast cancer

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

intravenous administration

Arm A2

Cohort 2: Her2+ve breast cancer

Group Type EXPERIMENTAL

larotaxel (XRP9881)

Intervention Type DRUG

intravenous administration

trastuzumab

Intervention Type DRUG

intravenous administration

Arm B2

Cohort 2: Her2+ve breast cancer

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

intravenous administration

trastuzumab

Intervention Type DRUG

intravenous administration

Interventions

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larotaxel (XRP9881)

intravenous administration

Intervention Type DRUG

docetaxel

intravenous administration

Intervention Type DRUG

trastuzumab

intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No