OncoMatch/Clinical Trials/NCT05999149
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)
Is NCT05999149 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Camrelizumab Plus Chemotherapy and Famitinib and Camrelizumab Plus Chemotherapy for tnbc - triple-negative breast cancer.
Treatment: Camrelizumab Plus Chemotherapy and Famitinib · Camrelizumab Plus Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) absence of expression
absence of HER2, ER, and PR expression
Required: ESR1 absence of expression
absence of HER2, ER, and PR expression
Required: PR (PGR) absence of expression
absence of HER2, ER, and PR expression
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Cannot have received: targeted therapy
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Cannot have received: radiation therapy
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4])
Cannot have received: VEGFR inhibitor (famitinib, sorafenib, sunitinib, regorafenib)
Exception: except bevacizumab
Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab)
Lab requirements
Blood counts
Adequate hematologic function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate hematologic and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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