Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.

The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations. This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer: * The main study concerns 80 patients eligible for PAR

Trial Details

NCT ID
NCT05378204
Phase
NA
Sponsor
Institut Claudius Regaud
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Main study:
  • Sub-study:
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Caen, France|49.18585,-0.35912
  • Clermont-Ferrand, France|45.77969,3.08682
  • Dijon, France|47.31344,5.01391
  • La Roche-sur-Yon, France|46.66974,-1.42757

Key Eligibility Criteria

  • Women (or men) aged ≥ 18 years with histologically proven breast cancer
  • Metastatic relapse or locally advanced breast cancer
  • No-HER2 overexpression or amplification
  • Triple-negative (defines as ER\<1%, PR\<1% and HER2-negative as per ASCO CAP guidelines) or hormone receptor positive (defines as ER and/or PR ≥ 1%…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Negative Breast Cancer Trials on Trialify →