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A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer


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 death or receipt of new anticancer therapy, whichever was first.


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Description:

Progression free survival was defined as the time interval from the date of randomization to the date of first disease progression (as assessed by Independent Radiologic Review (IRR) based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria), or the date of death due to any cause, whichever occurred first. In the absence disease progression or death, the participant was censored at the date of the last valid tumor assessment performed before the cut-off date.

Outcome Time Frame:

until cut-off date established from deaths rate

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC11486

NCT ID:

NCT00938652

Start Date:

July 2009

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • triple negative breast cancer
  • metastatic breast cancer
  • Triple negative metastatic breast cancer
  • Breast Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteHattiesburg, Mississippi  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Reserach SiteBillings, Montana  
Reserach SiteDurham, North Carolina  
Reserach SiteColumbia, South Carolina  
Research SitesSeattle, Washington