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)

Phase 2

Completed

• Conditions: breast cancer; metastatic triple negative breast neoplasm; 10006291

• Registration Number: NL-OMON34839
• Lead Sponsor: Sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* Histologically documented breast cancer that is ER- negative, PR-negative, and HER2 non-overexpressing with metastases measurable by RECIST 1.1 criteria
* 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;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Good organ and marrow function (see protocol page 32 for laboratory values)
* Radiation therapy completed at least 7 days before study dosing on day 1;
*Central nervous system (CNS) metastases allowed under certain conditions (see protocol page 32)
* No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed and curatively treated >5 years ago)

Exclusion Criteria

*Systemic anticancer therapy within 14 days of the first dose of study drug;
*Prior treatment with gemcitabine, carboplatin, cisplatin or any PARP inhibitor;
*Has not recovered to grade 1 from AEs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0;
*Bone metastasis or skin metastasis only;
*Major medical conditions that might affect study participation (e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease);
*Concurrent radiation therapy intended to treat primary tumor not permitted throughout the course of the study; palliative radiation is acceptable;
* Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective response rate. The ORR will be evaluated every second cycle.</p><br>