Clinical trial NCT00813956: A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: triple negative breast cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Breast Cancer Research Foundation
First posted: 2008-12-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the 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.


Eligibility 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

Primary outcomes:
measure: pathologic complete response
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Comprehensive Cancer Center
state: California
city: Philadelphia
country: United States
facility: PrECOG
state: Pennsylvania
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM. Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105. J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.