Actively 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.
Led by Institut Claudius Regaud · Updated on 2026-02-20
120
Participants Needed
25
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men aged 18 years or older with histologically confirmed breast cancer
- Locally advanced or metastatic breast cancer
- No HER2 overexpression or amplification
- Triple-negative breast cancer (ER <1%, PR <1%, HER2-negative) or hormone receptor positive breast cancer (ER and/or PR ≥ 1%)
- Biopsiable metastases except bone metastases; archived biopsy within 3 months allowed if frozen and FFPE samples available
- ECOG Performance Status 0 to 2
- Measurable or evaluable disease per RECIST v1.1
- Deleterious germline BRCA1 and/or BRCA2 mutation, eligible for PARP inhibitor therapy
- Any number of prior therapies allowed
- PARP inhibitor treatment not yet started
- Women must be post-menopausal or willing to use effective contraception during PARP inhibitor treatment
- Able and willing to provide informed consent and comply with study protocol
- Affiliated with Social Health Insurance in France
You will not qualify if you...
- Abnormal coagulation preventing biopsy
- Bone metastases as the only site of biopsiable disease
- All targets in previously irradiated regions unless clear progression observed
- Active or progressing additional malignancy except treated basal or squamous cell skin carcinoma or in situ cervical cancer
- Untreated central nervous system metastases or carcinomatous meningitis
- Known HIV infection
- Active Hepatitis B or C infection
- Receiving other anti-cancer therapies
- Pregnant or breastfeeding
- Psychological, familial, geographic, or social conditions preventing informed consent or compliance
- Under legal protection or deprived of liberty by legal decision
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Institut Bergonie
Bordeaux, France
Actively Recruiting
2
Centre Francois Baclesse
Caen, France
Actively Recruiting
3
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
4
Centre Georges Francois Leclerc
Dijon, France
Withdrawn
5
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Actively Recruiting
6
Centre Oscar Lambret
Lille, France
Actively Recruiting
7
CHU de LIMOGES
Limoges, France
Actively Recruiting
8
Centre Leon Berard
Lyon, France
Actively Recruiting
9
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
10
Centre de Cancerologie Du Grand Montpellier
Montpellier, France
Actively Recruiting
11
Institut Regional Du Cancer de Montpellier
Montpellier, France
Actively Recruiting
12
CHU de Nimes
Nîmes, France
Actively Recruiting
13
Hopital Pitie Salpetriere
Paris, France
Actively Recruiting
14
Hopital Saint Louis
Paris, France
Actively Recruiting
15
Hopital Tenon
Paris, France
Actively Recruiting
16
INSTITUT CURIE - Site de Paris
Paris, France
Withdrawn
17
CENTRE ARMORICAIN DE RADIOTHERAPIE, IMAGERIE MEDICALE ET ONCOLOGIE - Hôpital privé des Côtes d'Armor
Plérin, France
Not Yet Recruiting
18
Chu de Poitiers
Poitiers, France
Actively Recruiting
19
Centre Eugene Marquis
Rennes, France
Withdrawn
20
Chu Saint Etienne
Saint-Etienne, France
Actively Recruiting
21
INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain
Saint-Herblain, France
Actively Recruiting
22
IUCT-O
Toulouse, France
Actively Recruiting
23
Chru de Tours
Tours, France
Actively Recruiting
24
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
25
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
F
Florence DALENC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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