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Study identifier: NCT05378204 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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.

Condition: Breast Cancer  ·  Sponsor: Institut Claudius Regaud

PhaseNA
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Florence DALENC  ·  05 31 15 51 04  ·  Dalenc.Florence@iuct-oncopole.fr

Always discuss trial participation with your own doctor first.

Locations (25)

Institut BergonieBordeaux, FranceRecruiting
Centre Francois BaclesseCaen, FranceRecruiting
Centre Jean PerrinClermont-Ferrand, FranceRecruiting
Centre Georges Francois LeclercDijon, FranceWithdrawn
Centre Hospitalier Départemental VendéeLa Roche-sur-Yon, FranceRecruiting
Centre Oscar LambretLille, FranceRecruiting
CHU de LIMOGESLimoges, FranceRecruiting
Centre Leon BerardLyon, FranceRecruiting
Institut Paoli CalmettesMarseille, FranceRecruiting
Centre de Cancerologie Du Grand MontpellierMontpellier, FranceRecruiting
Institut Regional Du Cancer de MontpellierMontpellier, FranceRecruiting
CHU de NimesNîmes, FranceRecruiting

+ 13 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05378204