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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

Breast Cancer

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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