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Poly(ADP-ribose) Polymerase Inhibitors

Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.

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.

Main 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).

Sub-study:

Florence DALENC

Monica ARNEDOS

Georges EMILE

Xavier DURANDO

Sylvain LADOIRE

Frank PRIOU

Nawale HAJJAJI

Elise DELUCHE

Olivier TREDAN

Anthony GONCALVES

Cristian VILLANUEVA

William JACOT

Frédéric FITENI

Jean-Philippe SPANO

Luis TEIXEIRA

Joseph GLIGOROV

Juliette MAINGUENE

Anne-Claire HARDY-BESSARD

Nicolas ISAMBERT

Thibault DE LA MOTTE ROUGE

Jean-Sébastien FRENEL

Gilles FREYER

Hélène VEGAS

Anne KIEFFER

Suzette DELALOGE

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.

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.

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.

Progression will be determined using RECIST v1.1 criteria.

Artios Pharma Ltd

Institut Claudius Regaud

Spots Global Cancer Trial Database for shieldin complex