NCT05475678RecruitingPhase 2

Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer

Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 369 (estimated)
First submitted: 19 Jul 2022
Start date: 20 Dec 2022
Primary completion date: 31 May 2025
Lead sponsor: Zhenzhen Liu
Diseases: Triple-negative breast cancer
NCT number: NCT05475678

What you commit to

Study type: Interventional · Phase 2
Planned participants: 369
From 20 Dec 2022 to the primary completion date, 31 May 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
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；

Other illness

The patient has evidence of metastatic breast cancer；
The patient has a second primary malignancy other than adequately treated skin cancer;
The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
The patient has severe lung or heart disease;
The patient has active hepatitis B and C;
The patient has a history of organ transplantation or bone marrow transplantation;
The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Other

pregnant or breastfeeding women;

Who the study is looking for

Age: 18-70 years old
cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
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)；
Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
Cardiac ultrasound EF value ≧55%；
Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
ECOG score≤1 point;
Sign informed consent；

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Henan Cancer Hospital Coordinator of this site? Confirm its status	Zhengzhou	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.