A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)

This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factors: clinical stage of the tumor (stage II; Stage III) and CD8 expression status (IHC ≥10%, \< 10%). Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitini

Trial Details

NCT ID
NCT05999149
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Camrelizumab Plus Chemotherapy and Famitinib
  • Camrelizumab Plus Chemotherapy
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Inclusion Criteria:
  • ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
  • Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study.

For full eligibility, visit ClinicalTrials.gov.

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