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

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

Trial Details

NCT ID

NCT06533384

Phase

PHASE3

Sponsor

Guangdong Provincial People's Hospital

Status

RECRUITING

Cancer Type

Triple Negative (TNBC) Breast Cancer

Interventions

As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.
9 cycles of Camrelizumab as adjuvant therapy.

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

Pathologically confirmed invasive breast cancer.
Negative expression of estrogen receptor (ER) and progesterone receptor (PR) according to immunohistochemistry (i.e., tumor cells showing positive …
Negative human epidermal growth factor receptor 2 (HER2) status as determined by immunohistochemistry: HER2 score of 0/1+ or, if the score is 2+, H…
Clinical tumor staging: T1c, N1-N2 or T2, N0-N2 or T3, N0-N2 or T4a-d, N0-N2.

For full eligibility, visit ClinicalTrials.gov.

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