Actively Recruiting
A Randomized, Open Label, Multicenter Phase III Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
Led by Fudan University · Updated on 2024-02-21
424
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of camrelizumab combined with chemotherapy, with or without famitinib, as neoadjuvant (pre-surgery) treatment in participants with early or locally advanced triple-negative breast cancer (TNBC). This Phase III, open-label, randomized, controlled study divides participants based on tumor stage and CD8 expression. The goal is to assess the pathological complete response rate and other survival outcomes after treatment and surgery. Participants are randomly assigned to one of two groups: one receives camrelizumab plus chemotherapy (albumin-paclitaxel and carboplatin) combined with famitinib, and the other receives camrelizumab plus chemotherapy without famitinib. After completing neoadjuvant therapy, participants suitable for surgery will undergo surgical treatment followed by pathological evaluation. Those in the experimental group continue receiving camrelizumab and famitinib for up to one year from the start of therapy, while those in the control group continue camrelizumab alone for the same duration. During the study, participants are monitored for disease progression, side effects, and overall safety. Imaging assessments according to RECIST 1.1 are performed before surgery to evaluate treatment response. After surgery, participants will be followed for at least two years to track event-free survival, disease-free survival, distant metastasis-free survival, and safety. Safety data collection continues from the time of consent until 28 days after study completion.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 70 years
- Early or locally advanced triple-negative breast cancer (TNBC) confirmed by histology (absence of HER2, ER, and PR expression)
- Tumor stage II or III
- ECOG Performance Status of 0 to 1
- Adequate hematologic and organ function
- Willingness to use effective contraception during the study period
You will not qualify if you...
- History of breast cancer or invasive malignancy within 5 years except treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Prior chemotherapy, targeted therapy, or radiation therapy within 12 months
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or agents targeting other co-inhibitory T-cell receptors
- Diagnosis of immunodeficiency or autoimmune diseases
- Immunosuppressive therapy within 4 weeks prior to study treatment
- Severe lung or heart disease
- Known active hepatitis B or C infection
- History of organ or bone marrow transplantation
- Pregnant or breastfeeding women
- Prior use of VEGFR-like tyrosine kinase inhibitors (except bevacizumab)
- Urinary protein of 2+ or more and confirmed urinary protein quantity over 1g in 24 hours urine test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 weeks
Participants receive camrelizumab plus chemotherapy with or without famitinib as neoadjuvant therapy for triple negative breast cancer.
Regular visits during treatment period
Trial Site Locations
Total: 2 locations
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
chen li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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