Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05085626
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced HER2 Negative Breast Carcinoma
  • HRD+Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • fluzoparib+chidamide — DRUG
    Arms A will be treated with fluzoparib in combination with cedaramide
  • fluzoparib+camrelizumab — DRUG
    Arms B will be treated with fluzoparib in combination with camrelizumab

Study Details

This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive HER2-negative advanced breast cancer.

Key Dates

Start date
Feb 8, 2021
Status verified
Sep 2022
Primary completion
Oct 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: fluzoparib+chidamide
    Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Chidamide: It is recommended to take 20 mg (4 tablets) twice a week, with an interval of no less than 3 days between doses (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), for 30 minutes. Until disease progression or intolerable to patient.
  • 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

ORR(objective response rate) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts