A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- 5 years Disease free survival(DFS)
研究概览
简要总结
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.
- •Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
- •ctDNA positive at baseline, after NAC or after surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Written informed consent to provide research blood samples and tumor samples
- •Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection
- •No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis
排除标准
- •Previously participated in other interventional trials
- •Previous malignancy within 3 years of breast cancer diagnosis
- •Pregnancy or breastfeeding
- •No written consent
- •Unable to receive standard NAC and subsequent radiotherapy(if needed)
- •Active autoimmune disease
研究组 & 干预措施
A
ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine
干预措施: Tislelizumab (Drug)
A
ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine
干预措施: capecitabine (Drug)
B
ctDNA positive, non-pCR Intervention: capecitabine(standard care)
干预措施: capecitabine (Drug)
C
ctDNA positive, pCR Intervention: capecitabine
干预措施: capecitabine (Drug)
结局指标
主要结局
5 years Disease free survival(DFS)
时间窗: 60 months
From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
次要结局
- objective response rate(ORR)(12 months)
- pathological complete remission(pCR) rate(12 months)
- brain metastasis rate(60 months)
- 10 years OS(120 months)
- 5 years overall survival(OS)(60 months)
- Number of Patients with Adverse Events as a Measure of Safety and Tolerability(12 months)
- 10 years DFS(120 months)
- Relapse and metastasis rate(24 months)
研究者
Liu Qiang
Doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University