RecruitingPhase 2NCT04892693

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency: A Phase II Clinical and Exploratory Biomarker Study of Talazoparib


Sponsor

Seoul National University Hospital

Enrollment

70 participants

Start Date

May 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD).


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a PARP inhibitor drug called talazoparib in patients with advanced or metastatic breast cancer whose tumors have DNA repair defects (such as BRCA1/2 mutations or other related gene abnormalities). PARP inhibitors work by blocking a mechanism cancer cells use to repair their DNA. **You may be eligible if...** - You are 19 or older with unresectable or metastatic breast cancer - Your tumor has been shown to have a homologous recombination deficiency (HRD) — a DNA repair defect — including BRCA1/2 mutations, or mutations in genes like ATM, CHEK1, CHEK2, PALB2, RAD51 family, or others - You have previously received a taxane chemotherapy (unless contraindicated) - Your cancer has measurably progressed on recent treatment - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have previously received a PARP inhibitor drug (unless you relapsed 6+ months after an adjuvant PARP inhibitor in a clinical trial) - You have had more than 3 prior lines of chemotherapy for advanced/metastatic disease - You have brain metastases that are unstable or symptomatic - You have severe GI disease that affects oral medication absorption - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or hepatitis C 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 Oral Capsule

\- Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT04892693


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