Multicenter, randomized, open label study evaluating a poly(ADP-ribose) polymerase-1(PARP-1) inhibitor, SAR240550 (BSI-201), administered twice weekly or weekly, in combination with gemcitabine/carboplatin, in patients with metastatic Triple Negative Breast Cancer (mTNBC)

sanofi-aventis recherche & développement0 sites160 target enrollmentNovember 23, 2009

ConditionsMetastatic Triple Negative Breast Cancer.MedDRA version: 12.0Level: PTClassification code 10055113Term: Breast cancer metastatic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Triple Negative Breast Cancer.
Sponsor: sanofi-aventis recherche & développement
Enrollment: 160
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 23, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

sanofi-aventis recherche & développement

Eligibility 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: \<10% tumor staining by immunohistochemistry \[IHC]), and HER2 non\-overexpressing by IHC (0,1\+) or IHC 2\+ and fluorescence in situ hybridization (FISH negative). Patients IHC 3\+ are not eligible;
•I 02\. Metastatic breast cancer with measurable disease by RECIST 1\.1 criteria;
•I 03\. Prior treatment that includes: \- never having received anticancer therapy for metastatic disease OR \- having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo\-adjuvant/adjuvant systemic therapy will be considered as a prior chemotherapy if the first relapse occurred less than 1 year after the last treatment administration). Platinum compounds are allowed as prior neo\-adjuvant/adjuvant therapy if the first relapse occured more than 1 year after the last administration;
•I 04\.Female \=18 years of age;
•I 05\.Eastern Cooperative Oncology Group (ECOG) performance status of 0\-1;
•I 06\.Organ and marrow function as follows: absolute neutrophil count (ANC) \=1500/mm3, platelets \=100,000/mm3, hemoglobin \=9g/dL, total bilirubin \=1\.0 x ULN (total bilirubin \=1\.5 x ULN is allowed in case of Gilbert's syndrome provided AST and ALT \<1\.5 x ULN ), serum creatinine \=1\.5 mg/dL or creatinine clearance \=60mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \=2\.5 times x ULN if no liver involvement or \=5 times x ULN with liver involvement;
•I 07\.Radiation therapy completed at least 7 days before study dosing on day 1; radiated lesions may not serve as measurable disease;
•I 08\.Central nervous system (CNS) metastases allowed if patient does not require steroids, whole brain XRT, gamma/cyber knife, and brain metastases are clinically stable without symptomatic progression;
•I 09\. For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy and during 3 months after the last study treatment administration;
•I 10\. No other diagnosis of malignancy (with exception of non\-melanoma skin cancer or a malignancy diagnosed and curatively treated \=5 years ago);

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 (except for alopecia);
•E 04\. Bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);
•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 (7 days wash\-out period is requested before receiving the study treatment);
•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.
•E 10\. Patients with history of lesions of mixed ER/PR/HER2 phenotypes or history of non TNBC