AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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.

RecruitingNAAges 18 Years - anyAllInstitut Claudius Regaud
💬

In plain words

What the trial is, and whether it could suit you

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, tu

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
MAIN STUDY INCLUSION CRITERIA: 1. Women (or men) aged ≥ 18 years with histologically proven breast cancer 2. Metastatic relapse or locally advanced breast cancer 3. No-HER2 overexpression or amplification 4. Triple-negative (defines as ER\<1%, PR\<1% and HER2-negative as per ASCO CAP guidelines) or hormone receptor positive (defines as ER and/or PR ≥ 1%) breast cancer 5. Patients with metastases that can be biopsied except bone metastases. At baseline, if patients already have an archived biopsy from a secondary or a primary site (if stage IV) of their current disease, this material can be used for the study, provided that, it was collected within 3 months prior enrollment and a frozen and a FFPE sample are both available for research 6. ECOG Performance Status ≤ 2 7. Patients must have measurable or evaluable disease according to RECIST v1.1 8. Patient with deleterious germline BRCA 1 and/or 2 mutation, eligible for PARP inhibitor therapy (olaparib or talazoparib), according each investigator 9. Any number of prior lines therapy are allowed 10. Current treatment with PARP inhibitor not yet started 11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period by PARP inhibitor 12. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 13. Patient affiliated to a Social Health Insurance in France NON-INCLUSION CRITERIA: 1. Abnormal coagulation contraindicating biopsy 2. Bone metastases when this is the only site of biopsiable disease 3. Patients with all target in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them 4. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer 5. Patients with known untreated CNS metastases and/or carcinomatous meningitis 6. Patients with a known history of Human Immunodeficiency Virus (HIV) 7. Patients with known active Hepatitis B or C 8. Patients should not be on any other anti-cancer therapy (chemotherapy, endocrine therapy, immunotherapy, tailored therapy or alternative investigational therapy) 9. Patient pregnant, or breast-feeding 10. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 11. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice) SUB-STUDY INCLUSION CRITERIA: 1. Women (or men) aged ≥ 18 years with histologically proven breast cancer 2. Metastatic relapse or locally advanced breast cancer 3. No-HER2 overexpression or amplification 4. Triple-negative (defines as ER\<1%, PR\<1% and HER2-negative as per ASCO CAP guidelines) or hormone receptor positive (defines as ER and or PR ≥ 1%) breast cancer 5. Patients with metastases that can be biopsied except bone metastases 6. ECOG Performance Status ≤ 2 7. Patients, with deleterious germline BRCA 1 and/or 2, in progression under PARPi alone (talazoparib or olaparib) 8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 9. Patient affiliated to a Social Health Insurance in France NON-INCLUSION CRITERIA: 1. Abnormal coagulation contraindicating biopsy 2. Bone metastases when this is the only site of biopsiable disease 3. Patient pregnant, or breast-feeding 4. Patients with a known history of Human Immunodeficiency Virus (HIV) 5. Patients with known active Hepatitis B or C 6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 7. Patients already participating in the main REPARP study 8. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
💊

What it tests

  • Main study:
  • Sub-study:
📍

Where

25 sites
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

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy