Spots Global Cancer Trial Database for PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
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Trial Identification
Brief Title: PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
Official Title: PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146
Study ID: NCT01074970
Conditions
Study Description
Brief Summary: The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.
Detailed Description: OUTLINE: This is a multi-center study. Safety Run-in will be for the first 12 patients on study only (6 in cohort 1 and 6 in cohort 2). Patients in the safety run will be included in the efficacy analysis on intent to treat basis: Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D 1,2,3 every 3 weeks x 4 cycles If cycle 1 is well tolerated, the dose of Rucaparib will be escalated from 16 mg to 24 mg for subsequent cycles in the cohort 1, and 24 mg to 30 mg in the cohort 2. If ≤ 1 of 6 patients in cohort 1 experiences DLT, cohort 2 will commence. If 2 or more of 6 patients in cohort 1 experience DLT, the study will be suspended and an amendment to explore lower doses will be considered. If ≤ 1 of 6 patients in cohort 2 experiences DLT, the randomized portion of the study will commence. If 2 or more of 6 patients experience DLT, the study will be suspended and an amendment to proceed with the randomized portion at the cohort 2 dose (24 mg) will be considered. During the randomized portion of the study, patients will be randomized to either Arm A or Arm B. Stratification factors: * Anthracycline vs. not * Residual LN involvement vs. No Residual LN involvement Arm A (Cisplatin Monotherapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles Arm B (Combination Therapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D1,2,3 every 3 weeks x 4 cycles Rucaparib maintenance 30 mg IV weekly x 24 weeks ECOG Performance Status 0-1 Life Expectancy: Not Specified Hematopoietic: * Hemoglobin (Hgb) \> 9.0 g/dL * Platelets \> 100 K/ mm3 * Absolute neutrophil count (ANC) \> 1.5 K/mm3 Hepatic: * Bilirubin \< upper limit of normal (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL) * Aspartate aminotransferase (AST, SGOT) \< 2.5 x ULN * Alanine aminotransferase (ALT, SGPT) \< 2.5 x ULN Renal: * Calculated creatinine clearance of \> 50 cc/min using the Cockcroft-Gault formula Cardiovascular: * Left ventricular ejection fraction within normal limits. * Patients with an unstable angina or myocardial infarction within 12 months of study entry are excluded. * No clinically significant arrhythmia or baseline ECG abnormalities in the opinion of the treating investigator.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Jude Heritage Healthcare, Fullerton, California, United States
University of California Los Angeles, Los Angeles, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Memorial Cancer Institute Breast Cancer Center, Hollywood, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Community Regional Cancer Center, Indianapolis, Indiana, United States
Horizon Oncology Research, Inc./IU Health Arnett, Lafayette, Indiana, United States
Monroe Medical Associates, Munster, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Metro Health Cancer Care, Wyoming, Michigan, United States
Siteman Cancer Center, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
The Center for Cancer & Hematologic Disease, Cherry Hill, New Jersey, United States
Virtua Health Cancer Program, Mount Holly, New Jersey, United States
South Jersey Health Care, Vineland, New Jersey, United States
Presbyterian Medical Group, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center: Albuquerque, Albuquerque, New Mexico, United States
HOPE a Women's Cancer Center, Asheville, North Carolina, United States
Seidman Cancer Center, Cleveland, Ohio, United States
Oregon Health Sciences University, Portland, Oregon, United States
Pinnacle Health Fox Chase Regional Cancer Center, Harrisburg, Pennsylvania, United States
Bux-Mont Oncology Hematology Associates (FCCC) at Grand View Hospital, Sellersville, Pennsylvania, United States
The West Clinic, Memphis, Tennessee, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Contact Details
Name: Kathy D. Miller, M.D.
Affiliation: Hoosier Cancer Research Network
Role: STUDY_CHAIR
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