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

September 13, 2013 updated by: Sanofi

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

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 patients with triple negative breast cancer (estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative).

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
519

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Sedona, Arizona, United States
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Research Site
    • California
      • Alhambra, California, United States
        • Research Site
      • Bakersfield, California, United States
        • Research Site
      • Campbell, California, United States
        • Research Site
      • Fullerton, California, United States
        • Research Site
      • Lancaster, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Nothridge, California, United States
        • Research Site
      • Oxnard, California, United States
        • Research Site
      • Palo Alto, California, United States
        • Research Site
      • Pomona, California, United States
        • Research Site
      • Redondo Beach, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Barbara, California, United States
        • Research Site
      • Santa Maria, California, United States
        • Research Site
      • Sylmar, California, United States
        • Research Site
      • Vallejo, California, United States
        • Research Site
      • Westlake Village, California, United States
        • Research Site
      • Whittier, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
      • Grand Junction, Colorado, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Bonita Springs, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Ocoee, Florida, United States
        • Research Site
      • Orange Park, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Port St Lucie, Florida, United States
        • Research Site
    • Georgia
      • Albany, Georgia, United States
        • Research Site
      • Athens, Georgia, United States
        • Research Site
      • Atlanta, Georgia, United States
        • Research Site
      • Augusta, Georgia, United States
        • Research Site
      • Lawrenceville, Georgia, United States
        • Research Site
      • Macon, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Savannah, Georgia, United States
        • Research Site
    • Idaho
      • Coeur D'alene, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
      • Westwood, Kansas, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Chevy Chase, Maryland, United States
        • Research Site
      • Westminster, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Royal, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
      • Rochester, Minnesota, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • St Louis, Missouri, United States
        • Research Site
    • Montana
      • Billings, Montana, United States
        • Reserach Site
    • Nebraska
      • Grand Island, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Hampshire
      • Hooksett, New Hampshire, United States
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States
        • Research Site
      • Sparta, New Jersey, United States
        • Research Site
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Research Site
    • New York
      • Amsterdam, New York, United States
        • Research Site
      • East Setauket, New York, United States
        • Research Site
      • New York City, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Reserach Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Reserach Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Bedford, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Fort Worth, Texas, United States
        • Research Site
      • Fredericksburg, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Tyler, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
      • Roanoke, Virginia, United States
        • Research Site
      • Suffolk, Virginia, United States
        • Research Site
    • Washington
      • Kennewick, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Sites
      • Vancouver, Washington, United States
        • Research Site
      • Yakima, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm G/C
gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s)
Drug: gemcitabine/carboplatin

Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)

Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)
Experimental: Arm G/C/I
gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s)
Drug: gemcitabine/carboplatin

Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)

Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)

Drug: Iniparib

Body weight adjusted dose

intravenous infusion (60 ± 10 minutes)

Other Names:
  • BSI-201
  • SAR240550

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: until cut-off date established from deaths rate

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.
until cut-off date established from deaths rate
Overall survival
Time Frame: until cut-off date established from deaths rate

Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.

In the absence of confirmation of death, participant was censored at the last date he/she was known to be alive, or at the cut-off date, whichever was earlier.
until cut-off date established from deaths rate

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best overall response
Time Frame: until treatment discontinuation (assessment at the end of cycle 2 then every other cycle)
Best overall response was defined as the best evaluation observed through the entire treatment period as assessed by Independent Radiologic Review [IRR] based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
until treatment discontinuation (assessment at the end of cycle 2 then every other cycle)
Objective response rate
Time Frame: until treatment discontinuation (assessment at the end of cycle 2 then every other cycle)
Objective response rate was defined as the percentage of patients with IRR confirmed partial response or complete response prior to disease progression or treatment discontinuation.
until treatment discontinuation (assessment at the end of cycle 2 then every other cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC11486
  • 20090301 (Other Identifier: BiPar)
  • U1111-1119-8208 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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