Status:
COMPLETED
A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patie...
Detailed Description
Participants were treated for 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. After treatment discontinuation, participants were followed until end of study or d...
Eligibility Criteria
Inclusion
- \- Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-overexpressing by immunohistochemistry (0, 1) or fluorescence in situ hybridization (FISH).
- Triple-negative tumors were defined by the following criteria:
- HER2-non-overexpressing: FISH-negative (defined by ratio \<2.2) or, immunohistochemical (IHC) 0, IHC 1+ or, IHC 2+ or IHC 3+ and FISH-negative.
- ER- and PR-negative: \<10% tumor staining by immunohistochemistry (IHC).
- Never having received chemotherapy for metastatic disease or, having received 1 or 2 prior chemotherapy regimens in the metastatic setting (Prior adjuvant/neoadjuvant therapy was allowed);
- Metastatic breast cancer (Stage IV) with measurable disease by RECIST 1.1 criteria;
- Female, ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/dL, hemoglobin ≥9 g/dL, bilirubin ≤1.5 mg/dL, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement;
- Radiation therapy completed at least 14 days before study dosing on day 1; radiated lesions may not have served as measurable disease;
- Central nervous system metastases allowed if subject did not require steroids, whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were clinically stable without symptomatic progression;
- 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;
- Tissue block (primary or metastatic) or readily available fresh frozen tumor tissue for PARP expression and other pharmacogenomic studies recommended (although its absence will not exclude subjects from participating);
- No other diagnosis of malignancy (with exception of non melanoma skin cancer or a malignancy diagnosed ≥5 years ago);
- Obtained informed consent;
- Capability to understand and comply with the protocol and signed informed consent document.
Exclusion
- Systemic anticancer therapy within 14 days of the first dose of study drug;
- Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib
- Had not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0 or to within 10% of baseline values due to investigational drugs or other medications administered more than 30 days prior to study enrollment;
- Major medical conditions that might have affected 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 was acceptable;
- Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention;
- Pregnancy or breastfeeding;
- Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
519 Patients enrolled
Trial Details
Trial ID
NCT00938652
Start Date
July 1 2009
End Date
February 1 2012
Last Update
September 19 2013
Active Locations (102)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Sedona, Arizona, United States
3
Research Site
Jonesboro, Arkansas, United States
4
Research Site
Alhambra, California, United States