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.

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 23, 2022

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2027

Conditions
Breast Cancer
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).

Trial Locations (25)

Unknown

RECRUITING

Institut Bergonie, Bordeaux

RECRUITING

Centre Francois Baclesse, Caen

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

WITHDRAWN

Centre Georges Francois Leclerc, Dijon

RECRUITING

Centre Hospitalier Départemental Vendée, La Roche-sur-Yon

RECRUITING

Centre Oscar Lambret, Lille

RECRUITING

CHU de LIMOGES, Limoges

RECRUITING

Centre Leon Berard, Lyon

RECRUITING

Institut Paoli Calmettes, Marseille

RECRUITING

Centre de Cancerologie Du Grand Montpellier, Montpellier

RECRUITING

Institut Regional Du Cancer de Montpellier, Montpellier

RECRUITING

CHU de Nimes, Nîmes

RECRUITING

Hopital Pitie Salpetriere, Paris

RECRUITING

Hopital Saint Louis, Paris

RECRUITING

Hopital Tenon, Paris

WITHDRAWN

INSTITUT CURIE - Site de Paris, Paris

NOT_YET_RECRUITING

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

RECRUITING

Chu de Poitiers, Poitiers

WITHDRAWN

Centre Eugene Marquis, Rennes

RECRUITING

Chu Saint Etienne, Saint-Etienne

RECRUITING

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

RECRUITING

IUCT-O, Toulouse

RECRUITING

Chru de Tours, Tours

RECRUITING

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy

RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Artios Pharma Ltd

INDUSTRY

lead

Institut Claudius Regaud

OTHER

NCT05378204 - 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. | Biotech Hunter | Biotech Hunter