Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 344
- 试验地点
- 10
- 主要终点
- Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
研究概览
简要总结
This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
SECONDARY OBJECTIVES:
I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
- •Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
- •Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
- •Documented informed consent of the participant
排除标准
- •Allergy or intolerance to gadolinium
- •Inability to undergo breast MRI (e.g. claustrophobia)
- •Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
- •Previous diagnosis of stage 4 cancer
- •Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
- •Participants who have received endocrine therapy within 1 year prior to screening breast MRI
- •Participants who have received breast radiation within 1 year prior to screening breast MRI
- •Radiation to both breasts
- •Pregnant and/or lactating within 1 year prior to screening breast MRI
- •Receives screening breast MRIs at an outside facility other than the consenting institution
研究组 & 干预措施
Treatment (breast MRI, biopsy)
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (breast MRI, biopsy)
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
干预措施: Biospecimen Collection (Procedure)
Treatment (breast MRI, biopsy)
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
时间窗: Up to 12 months
Development of breast cancers other than triple-negative (e.g. estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) the study analysis, however they will be reported as descriptive statistics.
次要结局
- Expression of WNT10B/mutant p53 in morphologically normal breast tissue(Up to 12 months)