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

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Prosigna PAM-50 assay

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03749421

18-281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Prosigna Assay

Description:

* 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).

Treatment:

Other: Prosigna PAM-50 assay