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- To assess the objective response rate (ORR) of SAR240550 administered as a 60min intravenous infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC)
- To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks
- To assess Progression-free survival (PFS) and the overall survival (OS)
- To assess the safety profile of each schedule of SAR240550
- To evaluate the pharmacokinetic (PK) profile of SAR240550 in both arms (optional)
The duration of the study for a patient will include a period for inclusion of up to 3 weeks. The patients may continue treatment until disease progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment administration.
In case of discontinuation of study treatment, the patient will be considered as withdrawn from study treatment, and will be followed as planned for at least 30 days after the last administration of study treatment for safety purpose. In case of study treatment discontinuation without disease progression, efficacy data will be collected every 6 weeks until disease progression, death or study cut-off date whatever comes first. After the study cut-off date for primary analysis, the patient will be followed-up every 12 weeks (3 months) for efficacy until disease progression or end of study or for one year.
The patients who benefit from the study treatment can continue until disease progression, toxicity or willingness to stop.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Breast Cancer, Metastatic
SAR240550 (BSI-201), Gemcitabine, Carboplatin
Sanofi-Aventis Investigational Site Number 036002
Published on BioPortfolio: 2014-07-23T21:11:11-0400
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