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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: docetaxel; Drug: trastuzumab; Drug: larotaxel (XRP9881)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00485979

EudraCT 2006-006473-24

EFC10073

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 4 patient groups

Arm A1

Experimental group

Description:

Cohort 1: Her2-ve breast cancer

Treatment:

Drug: larotaxel (XRP9881)

Arm B1

Active Comparator group

Description:

Cohort 1: Her2-ve breast cancer

Treatment:

Drug: docetaxel

Arm A2

Experimental group

Description:

Cohort 2: Her2+ve breast cancer

Treatment:

Drug: trastuzumab

Drug: larotaxel (XRP9881)

Arm B2

Active Comparator group

Description:

Cohort 2: Her2+ve breast cancer

Treatment:

Drug: trastuzumab

Drug: docetaxel