Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs).
研究概览
简要总结
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
详细描述
Primary Objectives To describe the dynamic changes of ctDNA by binary MRD status (positive/negative) using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
Secondary Objectives To describe the dynamic changes of ctDNA by continuous quantitative tumor fraction using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Men or women who have a diagnosis of histological confirmed EBC (stage I, II or III) of any histopathology and any subtype (hormone-receptor positive or negative, HER2-positive, or negative).
- •Have tumor tissue available of sufficient quality for processing by Myriad Genetics.
- •Participant must be willing to provide serial blood samples at specific timepoints specific for each subgroup of interest per the Schedule of Activities
- •Age ≥18 years at enrollment
- •Arm A: Participants undergoing neoadjuvant systemic therapy: those with newly diagnosed untreated EBC of any subtype, stage I-II-II, who are scheduled to receive neoadjuvant systemic therapy of any type (i.e. chemotherapy, targeted therapy, immunotherapy, endocrine therapy) including a combination of agents, prior to undergoing breast surgery
- •Arm B: Participants with TNBC or HER2-positive EBC (T1a, T1b, N0): those with newly diagnosed and untreated TNBC or HER2-positive EBC who have a plan to undergo upfront breast surgery as part of their standard of care treatment
- •Arm C: Participants who receive an adjuvant CDK4/6-inhibitor (i.e., abemaciclib or ribociclib): those who have a diagnosis of hormone-receptor positive, HER2-negative, stage I-II-III EBC who have a plan to receive adjuvant abemaciclib or adjuvant ribociclib as part of their standard of care treatment
- •Arm D: Participants who receive an adjuvant PARP-inhibitor (i.e., olaparib): those who have a germline pathogenic mutation (i.e. BRCA) and a diagnosis of hormone-receptor positive or negative, HER2-negative, stage I-II-III EBC, and have a plan to receive an adjuvant PARPinhibitor as part of their standard of treatment plan
- •Arm E: Participants who develop ipsilateral locoregional recurrence (ILRR): those who have a diagnosis of EBC of any subtype, stage I-II-II and have completed local therapy (i.e. breast surgery and/or radiation therapy) and develop biopsy-proven locoregional disease recurrence in the ipsilateral breast and/or ipsilateral regional nodal basins
- •Arm F: Participants who completed local therapy and are 5 or more years out from breast surgery: those who have a diagnosis of EBC of any subtype, stage I-II-II, and have completed local therapy (i.e. breast surgery and/or radiation therapy), and are 5 or more years out from local therapy and do not have clinical evidence of disease
排除标准
- •Participants with distant cancer metastases (beyond locoregional disease recurrence)
- •Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- •Current or recent (within the last year) diagnosis of another primary malignancy (except skin cancer and non-invasive cancer)
- •Personal history of allogenic bone marrow or organ transplant
- •Participants who are pregnant
研究组 & 干预措施
Arm B
Participants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer.
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm E
Participants in Arm E have a history of EBC and have developed ipsilateral locoregional recurrence (the cancer has returned in the same area where the original tumor was).
干预措施: Neoadjuvant treatment (Drug)
Arm A
Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery)
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm A
Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery)
干预措施: Neoadjuvant treatment (Drug)
Arm B
Participants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer.
干预措施: Neoadjuvant treatment (Drug)
Arm C
Participants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib).
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm C
Participants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib).
干预措施: Neoadjuvant treatment (Drug)
Arm D
Participants in Arm D are receiving adjuvant therapy with a PARPinhibitor (such as olaparib).
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm D
Participants in Arm D are receiving adjuvant therapy with a PARPinhibitor (such as olaparib).
干预措施: Neoadjuvant treatment (Drug)
Arm E
Participants in Arm E have a history of EBC and have developed ipsilateral locoregional recurrence (the cancer has returned in the same area where the original tumor was).
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm F
Participants in Arm F completed treatment for EBC and had breast surgery 5 or more years ago.
干预措施: Blood draw for the laboratory assessment (Diagnostic Test)
Arm F
Participants in Arm F completed treatment for EBC and had breast surgery 5 or more years ago.
干预措施: Neoadjuvant treatment (Drug)
结局指标
主要结局
Safety and adverse events (AEs).
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点