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Clinical Trial NSABP B-55

Title
A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Principal Investigator
Massimo Cristofanilli
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.NSABP B-55
Purpose
This is a Phase III study to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)
Overview
This study will allow the researchers to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Eligibility
Some of the eligibility criteria include:
  • • Female or Male participants must be 18 years of age or older. a) For patients who underwent initial surgery and received adjuvant chemotherapy -TNBC patients must have been axillary node-positive (>/= pN1, any tumor size) or axillary node negative (pN0) with invasive primary tumor pathological size > 2 cm (>/= pT2). -ER and/or PgR positive/HER 2 negative patients must have had >/= 4 pathologically confirmed positive lymph nodes. b) For patients who underwent neoadjuvant chemotherapy followed by surgery -TNBC patients must have residual invasive breast cancer in the breast and/or resected lymph nodes (non-pCR) -ER and/or PgR positive/HER2 negative patients must have residual invasive cancer in the breast and/or the resected lymph nodes (non-pCR) AND a CPS&EG score >/= 3. Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
This study has two study groups. Group 1 will receive a placebo in the form of a tablet that looks like the study drug but contains no medication, and Group 2 will receive the study drug olaparib in the form of a tablet. A computer will by chance assign patients to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 24-Jun-17 08:59 PM

 

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