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)

Sponsor
Fudan University
Study ID
NCT05999149
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

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

Interventions

Study Details

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 famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy. Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received surgical treatment, and pathological evaluation of tumor efficacy was performed after surgery. During the study treatment, if the subjects show disease progression, toxicity intolerance, withdrawal of informed consent, or the investigator determines that medication must be terminated, the study treatment will be terminated, and follow-up will continue, including disease recurrence and metastasis and safety follow-up. Participants who complete surgical treatment will be followed for at least 2 years for event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), and safety assessment. Safety data should be collected from the signing of the informed consent until 28 days after the end of the study.

Key Dates

Start date
Aug 20, 2023
Status verified
Feb 2024
Primary completion
Aug 30, 2025
Completion
Aug 30, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Camrelizumab Plus Chemotherapy and Famitinib
  • Active Comparator: Arm B
    Camrelizumab Plus Chemotherapy

Primary Outcome Measure

Pathological complete response (pCR) rate [ Time Frame: Up to approximately 24 weeks ]

Central Contacts

Related Studies