Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 23

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 (other than totally resected or previously irradiated and nonprogressive/relapsed), 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 (DM1 or DM4 antibody-drug conjugates [ADCs]).
-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 (even if asymptomatic) 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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