Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer

Breast Cancer Clinical Trial

Official title:

Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03749421
• Other study ID #: 18-281
• Status: Active, not recruiting
• Start date: March 21, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• ER-negative and PR-negative invasive breast cancer (< 1% by IHC)
• Known metastatic disease

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Prosigna PAM-50 assay
Looks 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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	NanoString Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).	The association of the Prosigna test results to pathologic outcomes will be explored marginally in all patients who receive neoadjuvant treatment, and non-parametric Wilcoxon rank sum and Spearman test of correlation with two-sided alpha = 0.05 will be used to make inferences. Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes of response to neoadjuvant treatment.	2 years
Secondary	To assess if treatment change was based on ROR score, intrinsic subtype or both	Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes and response to neoadjuvant treatment. On the "Post-Prosigna Physician Questionnaire" physicians will be asked which of these item (ROR score, instrinsic subtype, or both) contributed to their neoadjuvant treatment decision-making.	2 years
Secondary	To evaluate physicians' confidence in their therapy before and after the test	Physicians will complete pre-test and post-test questionnaires that measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of physicians who are confident about their treatment recommendation. The same questions about confidence in diagnosis and treatment will be realized after Prosigna results and rates will be compared.	2 years
Secondary	To evaluate patients' confidence in their therapy before and after the test	Patients will complete pre-test and post-test questionnaires to measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of patients who understand their diagnosis and how Prosigna works and who are confident in treatment recommendation. The same question about diagnosis and treatment will be realized after Prosigna results and rates will be compared.	2 years