A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Invasive Disease Free Survival(IDFS)
研究概览
简要总结
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
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
- •Patient is ≥ 18 years-old at the time of consent to participate this trial
- •Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER <=1%, PR <=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
- •positive ctDNA after curative surgery and/or adjuvant chemotherapy
- •If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
- •Patient receives adjuvant chemotherapy according to the NCCN guidelines
- •Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
- •Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years
排除标准
- •Patient has previously received any PD1/PDL1 blockage treatment
- •Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
- •Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
- •Patient participates another interventional clinical trial
- •Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
- •Patient with autoimmune disease preventing the use of camrelizumab
- •Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
研究组 & 干预措施
Capecitabine
Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year
干预措施: capecitabine (Drug)
Capecitabine + Apatinib + Camrelizumab
Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day, Camrelizumab 200mg intravenously, once every two weeks (Q2W), oral apatinib, 250mg, PO, qd for 1 year
干预措施: capecitabine + camrelizumab + apatinib (Drug)
结局指标
主要结局
Invasive Disease Free Survival(IDFS)
时间窗: 60 months
Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
次要结局
- Distant disease-free survival(DDFS)(60 months)
- Overall Survival(60 months)
- Brain metastasis rate(60 months)
- The rate of adverse effects(AEs)(60 months)
研究者
Liu Qiang
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University