Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

Sponsor
Peking University People's Hospital
Study ID
NCT05576389
Phase
PHASE2
Status
Recruiting
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Conditions

  • Germline BRCA-mutated HER2-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab+Fluzoparib — DRUG
    Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle

Study Details

This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。

Key Dates

First listed
Oct 12, 2022
Start date
Oct 1, 2022
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Fluzoparib
    Fluzoparib combined with Carolizumab for 8 cycles of neoadjuvant therapy. Allowing the continued use of combination therapy or monotherapy with Carolizumab and fluzoparib during the adjuvant therapy phase, with an overall treatment duration not exceeding 12 months.

Primary Outcome Measure

tpCR（ypT0/is ypN0） [ Time Frame: 6 months ]

Central Contacts