NCT05475678 Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
| NCT ID | NCT05475678 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhenzhen Liu |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 369 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 369 participants in total. It began in 2022-12-20 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-70 years old 2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically； 3. Pathologically proven triple negative breast cancer: Triple-negative breast cancer is defined as: * Negative for ER and PR (IHC nuclear staining \<10%) * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)； 4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization； 5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy； 6. Cardiac ultrasound EF value ≧55%； 7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization; 8. ECOG score≤1 point; 9. Sign informed consent； Exclusion Criteria: 1. The patient has evidence of metastatic breast cancer； 2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received; 3. The patient has a second primary malignancy other than adequately treated skin cancer; 4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy； 5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease; 6. The patient has severe lung or heart disease; 7. The patient has active hepatitis B and C; 8. The patient has a history of organ transplantation or bone marrow transplantation; 9. pregnant or breastfeeding women; 10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Contact & Investigator
Zhenzhen Liu
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT05475678 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05475678 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05475678 currently recruiting?
Yes, NCT05475678 is actively recruiting participants. Contact the research team at liuzhenzhen73@126.com for enrollment information.
Where is the NCT05475678 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05475678 clinical trial?
NCT05475678 is sponsored by Zhenzhen Liu. The principal investigator is Zhenzhen Liu at Study Principal Investigator. The trial plans to enroll 369 participants.
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