Clinical Trials Logo

Clinical Trial Summary

This is a multicenter randomized phase ll clinical trial to evaluate the pathological complete response (pCR) in the tumour burden (primary and lymph nodes) with olaparib alone or in the olaparib and durvalumab arm in TNBC patients candidate for neoadjuvant strategy showing a t/gBRCAmut or BRCAness/HRD profile.


Clinical Trial Description

Eligible patients will be registered for central testing of BRCA mutatinal status and HRD/BRCAness profile with central review of ER, PgR, TILs and PD-L1. Eligible patients will be randomly assigned to either olparib or olaparib and durvalumab (=neoadjuvant treatment) in a 1:1 ratio. The treatment duration in both arms will last 16 weeks and both treatments are considered as experimental treatments in this study. After completion of neoadjuvant systemic treatment, patients will undergo surgery and followed-up for 2 years after investigational drug discontinuation. After surgery, adjuvant treatment will be left at the investigator's decision. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05209529
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Withdrawn
Phase Phase 2
Start date February 1, 2024
Completion date July 18, 2030

See also
  Status Clinical Trial Phase
Completed NCT04890327 - Web-based Family History Tool N/A
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Not yet recruiting NCT04055038 - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC) Phase 2/Phase 3
Recruiting NCT04566952 - Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Phase 2
Recruiting NCT04499534 - BRCA1/2 Flu Vaccine
Recruiting NCT05537844 - Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Active, not recruiting NCT03685331 - HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer Phase 1
Recruiting NCT05097274 - The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a BRCA Gene Mutation.
Completed NCT03428399 - Depression and Body Image Distress Following Mastectomy With Reconstruction
Completed NCT02957981 - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care N/A
Recruiting NCT04556071 - Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer Phase 2
Completed NCT04651920 - A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
Completed NCT02974842 - Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
Active, not recruiting NCT03351803 - BRCA Founder OutReach (BFOR) Study
Withdrawn NCT05062174 - Breast Cancer BRCA1 Carriers: a Pilot Study
Suspended NCT04151368 - Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy N/A
Active, not recruiting NCT04273542 - Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening N/A
Recruiting NCT05694715 - Combination Therapy in Cancers With Mutations in DNA Repair Genes Phase 1
Recruiting NCT06395519 - A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies Phase 1
Recruiting NCT05410951 - LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients