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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат （Carrelizumab + TCb） regimen
  Carrelizumab +docetaxel + carboplatin regimen
• Препарат TCb regimen
  docetaxel + carboplatin regimen

Первичные конечные точки

• Pathological complete response rate (pCR rate) [Срок оценки: up to 24 weeks]

Вторичные конечные точки (5)

• Event-Free Survival (EFS) [Срок оценки: 5-10 years after surgery.]
• DFS [Срок оценки: 5-10 years after surgery]
• Distant Disease Free Survival (DDFS) [Срок оценки: 5-10 years after surgery]
• Objective Response Rate (ORR) [Срок оценки: Preoperative]
• number of adverse events [Срок оценки: After each cycle of chemotherapy (21 days as 1 cycle)]

Критерии участия

Критерии включения

• 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；

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Henan cancer hospital — Чжэнчжоу

Идентификаторы

NCT: NCT05475678 · HELEN-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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