Actively Recruiting
Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency
Led by Seoul National University Hospital · Updated on 2025-04-17
70
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 years old or older
- Pathologically confirmed breast cancer that is unresectable or metastatic
- Tumor shows homologous recombination deficiency (HRD) by germline or somatic BRCA1/2 mutation, other homologous recombination repair gene mutations, or HRD detected by RAD51 foci assay
- Prior treatment with a taxane unless contraindicated
- Previous platinum therapy allowed if no progression during treatment and at least 6 months disease-free after neoadjuvant/adjuvant platinum
- Radiologic disease progression during or after most recent therapy or within 6 months post-adjuvant therapy
- At least 3 weeks since last chemotherapy
- At least 2 weeks since last hormone or radiation therapy
- ECOG performance status of 0 or 1
- At least one measurable lesion assessable by CT or MRI per RECIST v1.1
- Female patients of reproductive potential must agree to use effective contraception during and 7 months after treatment
- Adequate organ and marrow function within 28 days prior to treatment
- Negative urine pregnancy test within 7 days for premenopausal patients
- Ability to understand and comply with study protocol
- Signed informed consent before study entry
You will not qualify if you...
- Prior treatment with a PARP inhibitor, except if relapse occurred 6 months after adjuvant PARP inhibitor
- More than three previous lines of systemic chemotherapy, excluding neoadjuvant/adjuvant chemotherapy
- Availability of standard treatment for metastatic breast cancer
- History of other primary malignancies except certain treated cancers without active disease for 3 or more years
- Gastrointestinal conditions preventing oral medication absorption
- History of leptomeningeal carcinomatosis
- Symptomatic or uncontrolled brain metastases or spinal cord compression without stable disease
- Active infection or immunocompromised status including tuberculosis, hepatitis B or C, or HIV infection
- Known hypersensitivity to study drugs or excipients
- Pregnancy or breastfeeding
- Investigator judgment of unsuitability or unlikely compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Seock-Ah Im, MD, PhD
CONTACT
Y
Yuri Park, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here