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Scientists hunt for biomarkers of PARP inhibitor resistance in BRCA breast cancer

NCT ID NCT05378204

Knowledge-focused Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is collecting tumor and blood samples from 120 people with advanced, HER2-negative breast cancer who have a BRCA1/2 mutation. Researchers want to see if certain DNA repair proteins (POLQ, Shieldin complex, 53BP1) can predict whether a tumor will resist PARP inhibitor drugs like olaparib or talazoparib. The goal is to better understand resistance and potentially guide future treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify which patients are likely to resist PARP inhibitors, allowing more personalized treatment choices.
What could go wrong
This is an observational biomarker study, not a treatment trial. It may not lead to immediate clinical changes, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    NOT_YET_RECRUITING

    Plérin, France

  • CHU de LIMOGES

    RECRUITING

    Limoges, France

  • CHU de Nimes

    RECRUITING

    Nîmes, France

  • Centre Eugene Marquis

    WITHDRAWN

    Rennes, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, France

  • Centre Georges Francois Leclerc

    WITHDRAWN

    Dijon, France

  • Centre Hospitalier Départemental Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Leon Berard

    RECRUITING

    Lyon, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

  • Centre de Cancerologie Du Grand Montpellier

    RECRUITING

    Montpellier, France

  • Chru de Tours

    RECRUITING

    Tours, France

  • Chu Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • Chu de Poitiers

    RECRUITING

    Poitiers, France

  • Hopital Pitie Salpetriere

    RECRUITING

    Paris, France

  • Hopital Saint Louis

    RECRUITING

    Paris, France

  • Hopital Tenon

    RECRUITING

    Paris, France

  • INSTITUT CURIE - Site de Paris

    WITHDRAWN

    Paris, France

  • INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain

    RECRUITING

    Saint-Herblain, France

  • IUCT-O

    RECRUITING

    Toulouse, France

  • Institut Bergonie

    RECRUITING

    Bordeaux, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

  • Institut Regional Du Cancer de Montpellier

    RECRUITING

    Montpellier, France

  • Institut de Cancerologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, France

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