Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

Официальное название

A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation

Обзор

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.

Подробное описание

This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.

Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.

HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.

Вмешательства

• Препарат Camrelizumab
  Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle. Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.
• Препарат Fluzoparib
  Fluzoparib
• Препарат Nab-paclitaxel
  Nab-paclitaxel

Первичные конечные точки

• Pathologic Complete Response (pCR) [Срок оценки: Up to 32 weeks]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) [Срок оценки: Up to 32 weeks]
• Residual Cancer Burden (RCB) [Срок оценки: Up to 32 weeks]
• Event-Free Survival (EFS) [Срок оценки: Up to 20 years]
• Overall Survival (OS) [Срок оценки: Up to 20 years]
• Safety of drugs [Срок оценки: Up to 32 weeks]

Критерии участия

Критерии включения

• Histologically documented Her-2 negative
• TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
• No distant metastatic disease
• Eastern Cooperative Oncology Group Performance Status: 0\~1
• HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.

Критерии исключения

• Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
• Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
• Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
• Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
• Patients who have used immunosuppressive drug or corticosteroids within 14 days.
• Patients who have other diseases which researchers.
• Patients who allergy to any of the drugs in this trail.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT05761470 · 20220430GD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗