An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

Hebei Medical University Fourth Hospital0 sites30 target enrollmentSeptember 1, 2026

ConditionsSolid Tumor

InterventionsOlaparib

DrugsOlaparib

Overview

Phase: Phase 2
Intervention: Olaparib
Conditions: Solid Tumor
Sponsor: Hebei Medical University Fourth Hospital
Enrollment: 30
Primary Endpoint: ORR ORR
Status: Not Yet Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, single-arm, single-center,exploratory clinical study.

Detailed Description

This is an open-label, single-arm, single-center,exploratory clinical study initiated by the investigator to evaluate the efficacy of olaparib in recurrent and metastatic TNBC without BRCA1/2 mutation and methylated BRCA1 promoter.

Registry

clinicaltrials.gov

Start Date

September 1, 2026

End Date

September 1, 2031

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hebei Medical University Fourth Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1\. Age 18-70 years old, female;
•Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation.
•Note: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR negative were defined as: ER\<1% positive, PR\<1% positive. HER2 negativity was defined as: HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.
•3\. The number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines.
•4\. According to RECIST1.1 criteria, there is at least one evaluable lesion;
•ECOG physical condition score ≤ 1 point;
•Expected survival period ≥ 3 months;

Exclusion Criteria

•1\. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures;
•Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment;
•Previous use of PARP inhibitors, including olaparib and other PARP inhibitors;
•Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval\>450ms;
•The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia);
•Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy;
•Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases;
•History of severe central nervous system disease (including epilepsy patients);
•In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment;
•Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections;