Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
研究概览
简要总结
This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.
详细描述
As the investigators understanding of how ER-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery.
Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.
Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.
This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer
- •ER or PR ≥ 1% by immunohistochemistry (IHC)
- •HER2-negative status, according to guidelines by ASCO CAP guidelines:
- •https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751
- •Tumor size ≥ 0.5cm (clinical or radiographic measurements)
- •Any nodal status allowed
- •Age > 18 years old
- •Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician
排除标准
- •ER-negative and PR-negative invasive breast cancer (< 1% by IHC)
- •Known metastatic disease
研究组 & 干预措施
Prosigna Assay
- Biopsy specimen will be subject to molecular profiling via the Prosigna PAM-50 assay
- The results of Prosigna assay will be provided to the study team in a standardized report.
- This report will include the patient's intrinsic subtype, ROR score, and general risk (high, intermediate, low).
干预措施: Prosigna PAM-50 assay (Other)
结局指标
主要结局
The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
时间窗: 2 years
Questionnaires will be used to record neoadjuvant treatment decisions pre- and post-test. Data will be summarized in a contingency table, and the extent to which decisions changed will be estimated as the proportion of discordant responses and reported with a two-sided exact 95% confidence interval.
次要结局
- To assess if treatment change was based on ROR score, intrinsic subtype or both(2 years)
- To evaluate physicians' confidence in their therapy before and after the test(2 years)
- To evaluate patients' confidence in their therapy before and after the test(2 years)
- The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).(2 years)
研究者
Sara Tolaney, MD
Principal Investigator
Dana-Farber Cancer Institute