Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: （Carrelizumab + TCb） regimen, TCb regimen.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Triple Negative Breast Cancer, Camrelizumab. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
This study mainly compared the efficacy and safety of 6\*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6\*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.
Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.
* The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle. * The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.
The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.
Interventions
- Drug （Carrelizumab + TCb） regimen
Carrelizumab +docetaxel + carboplatin regimen - Drug TCb regimen
docetaxel + carboplatin regimen
Primary outcome measures
- Pathological complete response rate (pCR rate) [Time frame: up to 24 weeks]
Secondary outcome measures (5)
- Event-Free Survival (EFS) [Time frame: 5-10 years after surgery.]
- DFS [Time frame: 5-10 years after surgery]
- Distant Disease Free Survival (DDFS) [Time frame: 5-10 years after surgery]
- Objective Response Rate (ORR) [Time frame: Preoperative]
- number of adverse events [Time frame: After each cycle of chemotherapy (21 days as 1 cycle)]
Eligibility criteria
Inclusion criteria
- 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；
Exclusion criteria
- The patient has evidence of metastatic breast cancer；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- 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；
- 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;
- pregnant or breastfeeding women;
- The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Henan cancer hospital — Zhengzhou
Identifiers
NCT: NCT05475678 · HELEN-011