Metastatic Triple Negative Breast Cancer. MedDRA version: 12.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients must meet the following criteria to be enrolled in the study: I 01.Histologically documented breast cancer (either primary or metastatic site) that is ER- negative, PR-negative (for ER- and PR-negative: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: E 01.Systemic anticancer therapy within 14 days of the first dose of study drug; E 02.Prior treatment with gemcitabine, carboplatin, cisplatin or any PARP inhibitor; E 03.Has not recovered to grade =1 from AEs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0; E 04.Bone metastasis or skin metastasis only; E 05.Major medical conditions that might affect study participation (e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease); E 06.Concurrent radiation therapy intended to treat primary tumor not permitted throughout the course of the study; palliative radiation is acceptable; E 07.Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention; E 08.Pregnant or breast-feeding women; E 09.Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee. Confirmation of eligibility criteria is required for all potential study patients PRIOR to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective response rate (ORR) of SAR240550 administered as a 60min intravenous infusion twice weekly (arm A) or weekly (arm B), in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC).;Secondary Objective: •To assess the safety profile in arm A and in arm B. •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 in arm A and in arm B. •Progression-free survival (PFS) and the overall survival (OS) in both arms in arm A and in arm B. •To evaluate the pharmacokinetic (PK) profile of SAR240550 in both arms (optional). •To assess the biological activity of the study treatment on tumor tissue in both arms (optional). •To characterize the molecular and biological profile of tumors (optional). •To assess the effect of SAR240550 on PAR level on PBMC in both arms (optional).;Primary end point(s): Efficacy parameters: The primary efficacy endpoint is the ORR that is defined in the RECIST 1.1 version, as: complete response (CR) rate + partial response (PR) rate. Tumor measurements will be assessed at baseline (within 2 weeks before randomization) and then every 2 cycles (6 weeks) until disease progression. The data will be reviewed by the IRRC. | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Outcome results
None listed