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 not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobry stan ogólny (ECOG 0-1)
- •Rak piersi potrójna-negatywny (bez białek HER2, ER, PR) potwierdzone badaniem histologicznym
- •Guz w stadium II-III
- •Prawidłowe funkcje krwi i narządów
- •Gotowość stosowania skutecznej antykoncepcji przez czas trwania badania
✗ Disqualifies
- •Historia raka piersi
- •Inny nowotwór złośliwy w ciągu ostatnich 5 lat (poza rakiem skóry lub rakiem szyjki macicy in situ)
- •Chemioterapia, terapia celowana lub radioterapia w ostatnich 12 miesiącach
- •Poprzednia terapia anty-PD-1, anty-PD-L1, anty-PD-L2 lub podobne leki immunologiczne
- •Niedobór odporności lub choroby autoimmunologiczne
- •Leczenie immunosupresyjne w ciągu ostatnich 4 tygodni
- •Ciężka choroba płuc lub serca
- •Aktywne zapalenie wątroby typu B lub C, przeszczepienie narządu/szpiku
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- February 21, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, China
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, China
Trial contact
chen li, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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