Actively Recruiting
Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of 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 special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored. Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety. Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
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
CONTACT
D
Dechuang Jiao
CONTACT
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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