Use of a Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in Patients With BRCA-associated Triple-negative Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathomorphological response
研究概览
简要总结
This study was designed to evaluate the safety and efficacy of neoadjuvant therapy with mitomycin and carboplatin in patients with BRCA-associated locally advanced triple-negative breast cancer.
详细描述
The study includes two groups: one is an experimental group receiving chemotherapy according to the MCarb-T regimen, which is compared to a control group treated with the standard AC-TCarb regimen. To participate in this study, patients must have histologically confirmed triple-negative breast cancer (TNBC) in a locally advanced stage and a germline BRCA1 or BRCA2 mutation. All patients with TNBC undergo BRCA1/BRCA2 mutation testing before starting treatment, using either polymerase chain reaction (PCR) or next-generation sequencing (NGS).
Patients in the experimental group receive 4 cycles of neoadjuvant chemotherapy with the MCarb regimen (mitomycin + carboplatin AUC5), followed by 12 weekly doses of paclitaxel. Patients in the control group receive 4 cycles of neoadjuvant chemotherapy with the AC regimen (doxorubicin + cyclophosphamide), followed by 12 weekly administrations of the TCarb regimen (paclitaxel + carboplatin AUC2).
Clinical assessment is performed after cycles 2 and 4 of MCarb/AC, as well as after completion of the 12 weekly doses of T/ TCarb, with response evaluation according to RECIST 1.1 criteria.
Upon completion of cytotoxic chemotherapy, patients undergo surgical treatment. Resected specimens are evaluated using the Miller-Payne grading system and the Residual Cancer Burden (RCB) classification to determine the efficacy of systemic therapy.
To assess the safety of neoadjuvant systemic therapy, the frequency and nature of adverse events are recorded during treatment using the NCI CTCAE version 5.0 criteria. As part of the study protocol, complete blood counts with differential and platelet counts (Fonio method) were performed every 7 days, while blood biochemistry, urinalysis, and coagulation tests were carried out every 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent to participate in the study;
- •Histopathological confirmation of triple-negative breast cancer;
- •Stage: clinical T1-T4, N0-3, M0;
- •Positive molecular genetic test for BRCA1|2 gene mutation (PCR test or NGS result);
- •Age > 18 years;
- •ECOG status 0-1.
排除标准
- •Prior administration of any systemic therapy for breast cancer;
- •Stage IV disease;
- •Severe uncontrolled chronic comorbidities or acute illnesses;
- •Renal dysfunction;
- •Age > 70 years;
- •Presence of a second malignant tumor (except for previously cured malignancies);
- •Pregnancy or breastfeeding;
- •Negative molecular genetic test for BRCA1|2 gene mutation
研究组 & 干预措施
MCarb - T (mitomycin + carboplatin, paclitaxel)
mitomycin at a dose of 10 mg/m2, carboplatin AUC5, paclitaxel 80 mg/m2
干预措施: Neoadjuvant Chemotherapy (NACT) (Procedure)
AC - TCarb (doxorubicin + cyclophosphamide, paclitaxel + carboplatin)
doxorubicin at a dose of 60 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 80 mg/m2, carboplatin AUC2
干预措施: Neoadjuvant Chemotherapy (NACT) (Procedure)
结局指标
主要结局
Pathomorphological response
时间窗: From enrollment to pathological assessment (after surgery) from 6 to 7 months
The pathological response assessment will be performed within 14 days after definitive breast surgery. The Miller-Payne grading system will be used to assess the pathological response in the surgical specimen by comparing residual invasive tumor cellularity with the pretreatment core needle biopsy specimen. The Residual Cancer Burden (RCB) will be assessed using the surgical specimens from the breast and regional lymph nodes and will also be calculated within 14 days after surgery.
次要结局
- Adverse events incidence(Until 30 days after last patient treatment visit)
- Response rate(At the end of Cycle 2 (each cycle consists of 28 days). At the end of Cycle 4 (each cycle consists of 28 days). At the end of Cycle 6 (each cycle consists of 7 days). At the end of Cycle 12 (each cycle consists of 7 days).)
- overall and disease-free survival("through study completion, an average of 1 year")