A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	BiPar Sciences Breast Cancer Research Foundation
Information provided by:	BiPar Sciences
ClinicalTrials.gov Identifier:	NCT00813956

Purpose

This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery.

Condition	Intervention	Phase
Triple Negative Breast Cancer	Drug: gemcitabine plus carboplatin plus BSI-201	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by BiPar Sciences:

Primary Outcome Measures:

pathologic complete response [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental standard chemotherapy plus BSI-201	Drug: gemcitabine plus carboplatin plus BSI-201 iv, 3 week cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

invasive breast cancer
stage I-IIIA disease
ER, PR, Her2/neu-negative status
no prior treatment for breast cancer
age 18 years of greater
normal renal, liver function
normal hematologic status
ECOG Performance status 0, 1
Evaluation by a surgeon to determine breast conservation eligibility
Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Metastatic breast cancer
Inoperable breast cancer, including Stage IIIB and IIIC
Tumor size less than 1 centimeter
Prior surgery, systemic therapy, or radiotherapy for the current cancer
Hormone receptor-positive breast cancer
Her2/neu-positive breast cancer
Any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
Pregnant or nursing women
Receipt of any investigational agents within 30 days prior to commencing study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813956

Locations

United States, California
Stanford Comprehensive Cancer Center
stanford, California, United States, 94305

Sponsors and Collaborators

BiPar Sciences

Breast Cancer Research Foundation

More Information

Responsible Party:	BiPar Sciences Inc ( VP Clinical Development )
Study ID Numbers:	20060206
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00813956
Health Authority:	United States: Food and Drug Administration

Keywords provided by BiPar Sciences:

triple negative breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Carboplatin
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 13, 2009