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RECRUITING
NCT05378204
NA

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.

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-06-23

Completion Date

2027-06

Last Updated

2026-02-20

Healthy Volunteers

No

Conditions

Interventions

OTHER

Main study:

For each included patient, tumor biopsy specimen and blood samples will be collected at baseline visit (before the first dose of PARPi treatment). During the treatment period: blood samples will be scheduled every 8 weeks (i.e. 2 cycles). At the time of progression: tumor biopsy and blood samples will be collected.

OTHER

Sub-study:

For each included patient, tumor biopsy specimen and blood samples will be collected as soon as possible after progression (before initiation of the post PARPi anti-tumoral treatment).

Locations (25)

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

Chu Saint Etienne

Saint-Etienne, France

INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain

Saint-Herblain, France

IUCT-O

Toulouse, France

Chru de Tours

Tours, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France