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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.

Study acronym: REPARP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Collaborators shortened, about 3 wordsv23
  2. Minor Site details revised at 3 of 25 sitesv22
  3. Notable Primary completion date: Jan 2025 to Jan 2027
    • Study completion date: Jun 2025 to Jun 2027
    v21
  4. Minor Site details revised at 1 of 25 sitesv20
  5. Minor Study sites: 24 to 25v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Study sites: 23 to 24v18
  2. Minor Study sites: 22 to 23v17
  3. Minor Study sites: 21 to 22v16
  4. Minor Site details revised at 1 of 21 sitesv15
  5. Minor Site details revised at 1 of 21 sitesv14
  6. Minor Site details revised at 1 of 21 sitesv13
  7. Minor Site details revised at 1 of 21 sitesv12
  8. Minor Site details revised at 2 of 21 sitesv11
  9. Minor Site details revised at 1 of 21 sitesv10
  10. Minor Site details revised at 1 of 21 sitesv9
  11. Minor Site details revised at 1 of 21 sitesv8
  12. Minor Site details revised at 2 of 21 sitesv7
  13. Minor Site details revised at 1 of 21 sitesv6
  14. Minor Site details revised at 1 of 21 sitesv5
  15. Minor Site details revised at 1 of 21 sitesv4
  16. Minor Start date changed from estimate of Jun 2022 to Jun 23, 2022v3
  17. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 21 of 21 sites
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration. * The sub-study concerns 40 patients in progression disease under PARPi alone. For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study.
Trial Details
NCT Number NCT05378204
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov