Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer

Conditions

• Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Fluzoparib — DRUG
  Arms A will be treated with fluzoparib alone
• Fluzoparib+Camrelizumab — DRUG
  Arms B will be treated with fluzoparib in combination with camrelizumab

Study Details

This study is planned to include 80 patients with HRD positive HER2-negative advanced breast cancer to receive fluzoparib alone or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with or without camrelizumab in the treatment of HRD positive HER2-negative advanced breast cancer.

Key Dates

Start date

Nov 23, 2022

Status verified

Jan 2026

Primary completion

Mar 30, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: fluzoparib
  Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.
• Experimental: fluzoparib+Camrelizumab
  Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 3 years ]