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

StatusCompleted
PhaseNot specified
Started2019-03-21
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Trial completed
Study completion confirmed: August 2025 (last estimated December 2026)
2026-02-04
Study Status, Oversight v9
Completion date2025-12-31→2026-12-31
2025-02-11
Study Status, Oversight v8
Completion date2024-12-31→2025-12-31
2024-04-15
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Completion date2024-01-31→2024-12-31
Study sitesdetails revised at 1 of 1 site
2023-12-11
Study Status v6
Primary completion dateestimated 2023-09-30→confirmed 2023-11-29
Show 5 earlier versions
2023-01-09
Study Status, Sponsor/Collaborators v5
Primary completion date2022-09-30→2023-09-30
2022-04-05
Study Status v4
Primary completion date2022-01-31→2022-09-30
2021-06-07
Study Status v3
Primary completion date2021-01-31→2022-01-31
Completion date2023-01-31→2024-01-31
2020-08-12
Study Status v2
Primary completion date2020-07-01→2021-01-31
Completion date2022-01-31→2023-01-31
2019-04-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-11-30→confirmed 2019-03-21
Study sites1 entry, revised
Dana-Farber Cancer Institute
2018-11-17
Original filing
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.
Trial Details
NCT Number NCT03749421
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: NanoString Technologies, Inc.
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2019-03-21
Primary Completion 2023-11-29 (estimated)
Study Completion 2025-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-30