breast cancer mamma carcinoma
Conditions
Interventions
Patients receive 90 mg/m2 SAR566658 or 120 mg/m2 SAR566658 on day 1 and 8 of
each cycle.
breast cancer
efficacy
metastatic
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -Measurable Metastatic triple negative breast cancer (TNBC). -Patients with CA6-positive disease. -Patients received at least 1 prior chemotherapy regimen but no more than 3 for advanced/metastatic disease.;-Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant or metastatic setting.
Exclusion criteria
Exclusion criteria: -Eastern Cooperative Oncology Group (ECOG) performance status *2. -Patient less than 18 years old. -Pregnant or breast-feeding women. -Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of study drug. -Wash out period of less than 3 weeks or 5 half-lives from previous antitumor chemotherapy, immunotherapy, or any investigational treatment. -History of brain metastasis, spinal cord compression or carcinomatous meningitis, or new evidence of brain leptomeningeal disease. -Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments. -Known intolerance to infused protein products including other monoclonal antibodies and ADCs. -Poor bone marrow reserve and/or poor organ function. -Symptomatic peripheral neuropathy Grade *2. -Previous history of chronic corneal diseases or unresolved acute nonrecurrent corneal conditions. -Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study. -Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors, unless it can be discontinued at least 2 weeks before 1st administration of SAR566658. -Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected dose based on ORR. | — |
Secondary
| Measure | Time frame |
|---|---|
| -To assess: -Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP); -The impact of ocular primary prophylaxis on the incidence of keratopathies | — |
Countries
The Netherlands
Outcome results
None listed