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Spots Global Cancer Trial Database for 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.

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Trial Identification

Brief Title: 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.

Official Title: Prospective and Multicentric 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 ID: NCT05378204

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut Bergonie, Bordeaux, , France

Centre Francois Baclesse, Caen, , France

Centre Jean Perrin, Clermont-Ferrand, , France

Centre Georges Francois Leclerc, Dijon, , France

Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, , France

Centre Oscar Lambret, Lille, , France

CHU de LIMOGES, Limoges, , France

Centre Leon Berard, Lyon, , France

Institut Paoli Calmettes, Marseille, , France

Centre de Cancerologie Du Grand Montpellier, Montpellier, , France

Institut Regional Du Cancer de Montpellier, Montpellier, , France

CHU de Nimes, Nîmes, , France

Hopital Pitie Salpetriere, Paris, , France

Hopital Saint Louis, Paris, , France

Hopital Tenon, Paris, , France

INSTITUT CURIE - Site de Paris, Paris, , France

CENTRE ARMORICAIN DE RADIOTHERAPIE, IMAGERIE MEDICALE ET ONCOLOGIE - Hôpital privé des Côtes d'Armor, Plérin, , France

Chu de Poitiers, Poitiers, , France

Centre Eugene Marquis, Rennes, , France

INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain, Saint-Herblain, , France

Chu Saint Etienne, Saint-Étienne, , France

IUCT-O, Toulouse, , France

Chru de Tours, Tours, , France

Institut de Cancerologie de Lorraine, Vandoeuvre-les-nancy, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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