Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

Sponsor
Ying Lin
Study ID
NCT05761470
Phase
PHASE2
Status
Recruiting
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Conditions

  • HRR Gene Mutation
  • Her-2 Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle. Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.
  • Fluzoparib — DRUG
    Fluzoparib
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel

Study Details

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.

Key Dates

Start date
May 6, 2022
Status verified
Mar 2023
Primary completion
Jun 30, 2024
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Camrelizumab, Fluzoparib and Nab-paclitaxel
    Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.

Primary Outcome Measure

Pathologic Complete Response (pCR) [ Time Frame: Up to 32 weeks ]

Central Contacts