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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.
ClinicalTrials.gov ID: NCT05378204
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- MAIN STUDY
- Women (or men) aged ≥ 18 years with histologically proven breast cancer
- Metastatic relapse or locally advanced breast cancer
- No-HER2 overexpression or amplification
- 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%)...
See the full eligibility criteria
- MAIN STUDY
- Women (or men) aged ≥ 18 years with histologically proven breast cancer
- Metastatic relapse or locally advanced breast cancer
- No-HER2 overexpression or amplification
- 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
- 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...
- ECOG Performance Status ≤ 2
- Patients must have measurable or evaluable disease according to RECIST v1.1
- Patient with deleterious germline BRCA 1 and/or 2 mutation, eligible for PARP inhibitor therapy (olaparib or talazoparib), according each investigator
- Any number of prior lines therapy are allowed
- Current treatment with PARP inhibitor not yet started
- Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period by PARP inhibitor
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France NON-
- Abnormal coagulation contraindicating biopsy
- Bone metastases when this is the only site of biopsiable disease
- 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
- 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...
- Patients with known untreated CNS metastases and/or carcinomatous meningitis
- Patients with a known history of Human Immunodeficiency Virus (HIV)
- Patients with known active Hepatitis B or C
- Patients should not be on any other anti-cancer therapy (chemotherapy, endocrine therapy, immunotherapy, tailored therapy or alternative investigational therapy)
- Patient pregnant, or breast-feeding
- 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
- 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
- Women (or men) aged ≥ 18 years with histologically proven breast cancer
- Metastatic relapse or locally advanced breast cancer
- No-HER2 overexpression or amplification
- 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
- Patients with metastases that can be biopsied except bone metastases
- ECOG Performance Status ≤ 2
- Patients, with deleterious germline BRCA 1 and/or 2, in progression under PARPi alone (talazoparib or olaparib)
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France NON-
- Abnormal coagulation contraindicating biopsy
- Bone metastases when this is the only site of biopsiable disease
- Patient pregnant, or breast-feeding
- Patients with a known history of Human Immunodeficiency Virus (HIV)
- Patients with known active Hepatitis B or C
- 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
- Patients already participating in the main REPARP study
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- La Roche-sur-Yon, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nîmes, France
- Paris, France
- Plérin, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
- Saint-Herblain, France
- Toulouse, France
- Tours, France
- Vandœuvre-lès-Nancy, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Caen, France; Clermont-Ferrand, France; Dijon, France; La Roche-sur-Yon, France; Lille, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.