Status:
ACTIVE_NOT_RECRUITING
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
NanoString Technologies, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 t...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- ER-negative and PR-negative invasive breast cancer (\< 1% by IHC)
- Known metastatic disease
Key Trial Info
Start Date :
March 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03749421
Start Date
March 21 2019
End Date
December 31 2025
Last Update
February 13 2025
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215