Actively Recruiting
Study of Camrelizumab Combined With Docetaxel and Carboplatin Versus Docetaxel and Carboplatin Alone as Neoadjuvant Treatment for Triple Negative Breast Cancer
Led by Zhenzhen Liu · Updated on 2025-01-23
369
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Triple-negative breast cancer (TNBC) is a subtype of breast cancer lacking ER, PR, and Her-2 proteins, making up 15%-20% of all breast cancers. Patients with TNBC do not benefit from endocrine or HER-2-targeted therapies but are sensitive to chemotherapy. Despite recent improvements, TNBC still has the poorest prognosis among breast cancer types. This phase II study aims to investigate whether adding camrelizumab, a PD-1 inhibitor, to an anthracycline-free chemotherapy regimen (TCb) can improve treatment outcomes for lymph node-positive TNBC patients. The study compares two treatment groups: one receiving six cycles of TCb (docetaxel plus carboplatin) combined with camrelizumab, and the other receiving six cycles of TCb alone. Each cycle lasts 21 days. In the experimental group, docetaxel and carboplatin are given on day 1, and camrelizumab is given on day 3. The control group receives only docetaxel and carboplatin on day 1 of each cycle. This design tests the safety and effectiveness of adding camrelizumab to the chemotherapy regimen before surgery. Participants will be monitored through various assessments including pathological complete response rate, event-free survival, disease-free survival, distant disease-free survival, and overall response rate after surgery. Organ and bone marrow functions, cardiac function, and pregnancy status are checked before treatment. The study includes 24 weeks of treatment with detailed evaluations to track response and safety in female patients aged 18 to 70 years with confirmed TNBC.
CONDITIONS
Official 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 old
- Clinical tumor stage cT2 to cT4d, or cT1c with confirmed axillary lymph node metastasis
- Pathologically confirmed triple-negative breast cancer defined as ER and PR negative (IHC nuclear staining <10%) and Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)
- Measurable lesions on ultrasound, mammography, or optional MRI within 1 month before randomization
- Organ and bone marrow function tests within 1 month before chemotherapy showing no contraindications
- Cardiac ultrasound ejection fraction (EF) of at least 55%
- Negative serum pregnancy test for females of childbearing age within 14 days before randomization
- ECOG performance status score of 1 or less
- Signed informed consent
You will not qualify if you...
- Evidence of metastatic breast cancer
- Previous chemotherapy, endocrine therapy, targeted therapy, or radiation therapy for this disease
- Presence of a second primary malignancy except treated skin cancer
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or other immunotherapies
- Diagnosed with immunodeficiency or autoimmune diseases
- Severe lung or heart disease
- Active hepatitis B or C infection
- History of organ or bone marrow transplantation
- Pregnant or breastfeeding
- Other serious uncontrolled medical conditions making chemotherapy unsafe
AI-Screening
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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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