RecruitingPhase 2NCT06193525

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test: The FUTURE Trial


Sponsor

Erasmus Medical Center

Enrollment

66 participants

Start Date

Sep 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to prove that the RECAP test is capable of selecting advanced breast cancer patients sensitive for treatment with the PARP inhibitor talazoparib. Participants will undergo an ultrasound-guided biopsy and a blood withdrawal. Homologous Recombination (HR) deficient patients (approximately 30%) can start talazoparib treatment until progression of the disease or unacceptable side-effects and their response will be evaluated.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing talazoparib (a PARP inhibitor drug) in women with advanced or metastatic breast cancer who have signs of a specific DNA repair defect, identified by a special laboratory test called the RECAP test — not limited to those with known BRCA gene mutations. **You may be eligible if...** - You have locally advanced or metastatic breast cancer with no curative treatment options - Your cancer has progressed in the last 4 months - Your tumor is either triple-negative, high-grade ER-positive/HER2-negative, or has a confirmed DNA repair defect (HRD) on the RECAP test or a known BRCA1/2 mutation - You are able to undergo a biopsy of an accessible tumor site **You may NOT be eligible if...** - You have brain metastases that are not stable - You have had prior treatment with a PARP inhibitor - Your general health is too poor to tolerate treatment (WHO performance status > 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalazoparib

Talazoparib is administered daily as single agent, 1 mg orally until unacceptable toxicity or progression of disease.


Locations(3)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Groningen University Medical Center

Groningen, Netherlands

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NCT06193525


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