Chemotherapy Monitoring by Circulating Tumor DNA (ctDNA) in HER2 (Human Epidermal Growth Factor Receptor-2)- Metastatic Breast Cancer (MONDRIAN): a Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- LxC1 : ctDNA quantification
研究概览
简要总结
This is a one-arm, single site, open-label phase II study. Patients will be enrolled in the screening step at the start of the second line of chemotherapy, and will undergo blood draws for ctDNA detection. Patients for whom ctDNA was successfully detected and found informative by the study executive board could then be included in the interventional step when starting a new line of therapy.
ctDNA will be quantified using the customized test, at baseline and day 15 (+/- 3 working day) of cycle #1, and results will be made available before the cycle 2 Day 1, together with a treatment management recommendation by the Study Executive Board (continuation or discontinuation of the corresponding chemotherapy)
详细描述
Patients will be enrolled in the screening step at the start of the second line of chemotherapy, and will undergo blood draws for ctDNA detection:
That second line of treatment will be managed by clinical and radiological evaluations (RECIST); ctDNA will not be released to clinician and patient in real time.
While the included patient is being treated by second line therapy, a customized ctDNA detection based on tumor mutations (droplet-digital PCR) will be developed. Once set up, the two blood above-mentioned samples will be subjected to ctDNA detection. The SEB will then retrospectively assess whether ctDNA levels changes during the second line of treatment were indicative of the efficacy of the second line therapy. Patients for whom ctDNA was successfully detected and found informative by the SEB (Steering Executive Board) could then be included in the interventional step when starting a new line of therapy.
The third blood draw for ctDNA detection will be used to compare results to the tumor evaluation performed by imaging.
In the interventional step, ctDNA analyses and interpretation will be performed in real time; results made available before the cycle 2. Quantitative results will be interpreted by the laboratory committee, with two possible recommendations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm
Patients with HER2-negative metastatic breast cancer, starting a second line of chemotherapy
干预措施: Chemotherapy monitoring by circulating tumor DNA analysis (Biological)
结局指标
主要结局
LxC1 : ctDNA quantification
时间窗: At the Day 15 of the Cycle 1 (each cycle is 21 days)
ctDNA quantification (MAF %) during 4th chemotherapy line and following : Line x, 1st cycle (LxC1)
L3C1 : ctDNA quantification
时间窗: At the Day 15 of Cycle 1 (each cycle is 21 days)
ctDNA quantification (Mutant Allelic Frequency (MAF) %) during 3rd chemotherapy Line, 1st cycle (L3C1)
LxC1 : chemotherapy efficacy
时间窗: ctDNA difference between Day 15 and Day 1
ctDNA change : if major drop from D1 to D15 (MAF\>40%), no change on treatment recommanded If no major drop from D1 to D15, change of chemotherapy recommanded
L3C1 : chemotherapy efficacy
时间窗: ctDNA difference between Day 15 and Day 1
ctDNA change : if major drop from D1 to D15 (MAF\>40%), no change on treatment. If no major drop from D1 to D15, change of chemotherapy
Progression Free Survival (PFS)
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8-weeks up to 18 months
Tumor assessment (MRI and/or CT) by RECIST 1.1
次要结局
未报告次要终点