PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT06533384
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Triple-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach. Based on the classification according to their BRCA mutation status, patients with BRCA mutations choose the PD-1 inhibitor + PARPi regimen, while patients without BRCA mutations opt for the PD-1 inhibitor + capecitabine regimen. Compared to monotherapy with PD-1 inhibitors, these combination regimens may offer improved efficacy and acceptable tolerability. This study is designed as a prospective, randomized, controlled, open-label, single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA1/2 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment.

Key Dates

Start date
Aug 1, 2024
Status verified
Nov 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental ARM
    In the experimental group, patients with confirmed deleterious mutations based on germline BRCA1/2 status receive a combination of Fuzuloparib and Camrelizumab as adjuvant therapy. Patients without germline BRCA1/2 deleterious mutations receive a combination of capecitabine and Camrelizumab as adjuvant therapy.
  • Active Comparator: Control ARM
    9 cycles of Camrelizumab as adjuvant therapy.

Primary Outcome Measure

IDFS [ Time Frame: Up to approximately 5 years ]

Central Contacts

Related Studies