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

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03749421

Run by

Dana-Farber Cancer Institute

People needed

60

Starts

2019-03-21

Expected to finish

2026-12-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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