Actively Recruiting
Randomized Study of Camrelizumab Plus TCb Versus TCb Alone as Neoadjuvant Therapy for Triple Negative Breast Cancer
Led by Zhenzhen Liu · Updated on 2025-01-23
369
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Triple-negative breast cancer (TNBC) is a subtype of breast cancer that lacks ER, PR, and Her-2 proteins, making up 15%-20% of all breast cancers. TNBC patients do not benefit from endocrine or HER-2-targeted therapies but respond to cytotoxic drug treatments. Despite improvements, TNBC still has the worst prognosis among breast cancer types. This research evaluates camrelizumab combined with a less toxic anthracycline-free TCb regimen to find safer and more effective neoadjuvant therapy for lymph node-positive TNBC patients. The study compares the safety and effectiveness of two chemotherapy regimens given before surgery: one group receives six cycles of TCb (docetaxel and carboplatin) combined with camrelizumab, a PD-1 inhibitor, and the other group receives six cycles of TCb alone. Each cycle lasts 21 days, with docetaxel and carboplatin administered on the first day, and camrelizumab given on the third day for the experimental group. Participants are randomly assigned in a 2:1 ratio to either group. Participants will undergo assessments including pathological complete response rate within 24 weeks, and longer-term measures like event-free survival, disease-free survival, distant disease-free survival, and objective response rate after surgery. Safety is monitored by recording adverse events after each chemotherapy cycle. The study lasts up to 10 years with follow-up to evaluate long-term outcomes, and participants provide informed consent before enrollment.
CONDITIONS
Brief Title
Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Clinically and pathologically confirmed lymph node-positive triple-negative breast cancer
- Triple-negative breast cancer defined as ER and PR negative (less than 10% staining) and HER-2 negative
- Measurable lesions on ultrasound, mammography, or MRI within 1 month before randomization
- Normal organ and bone marrow function within 1 month before chemotherapy
- Cardiac ejection fraction of 55% or higher
- Negative pregnancy test for women of childbearing potential within 14 days before randomization
- ECOG performance status of 0 or 1
- Signed informed consent
You will not qualify if you...
- Evidence of metastatic breast cancer
- Prior chemotherapy, endocrine therapy, targeted therapy, or radiation for this disease
- Second primary cancer except adequately treated skin cancer
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immunotherapy
- Diagnosis of immunodeficiency or autoimmune disease
- Severe lung or heart disease
- Active hepatitis B or C infection
- History of organ or bone marrow transplantation
- Pregnant or breastfeeding women
- Serious uncontrolled medical conditions contraindicating chemotherapy due to investigator judgment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles, each 21 days)
Participants receive 6 cycles of neoadjuvant chemotherapy with either TCb plus camrelizumab or TCb alone.
6 treatment cycles with visits every 3 weeks
Duration - 5 to 10 years after surgery
Participants are monitored after surgery for up to 5 to 10 years to evaluate long-term outcomes and safety.
Regular follow-up visits as per surgical and oncology care
Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Z
Zhenzhen Liu
D
Dechuang Jiao
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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