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NCT03749421
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
trial testing Prosigna PAM-50 assay in Breast Cancer in 60 participants. Participants enrolled and being followed up; not accepting new ones.
29 November 2023
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 21 March 2019 |
| Primary completion | 29 November 2023 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prosigna PAM-50 assay
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
Ontario Health (Quality) . · · 2020 · cited 19× · PMID 32284770 -
Delineating intra-tumoral heterogeneity and tumor evolution in breast cancer using precision-based approaches.
Xulu KR, Nweke EE, Augustine TN. · · 2023 · cited 7× · PMID 37662839 · DOI 10.3389/fgene.2023.1087432 -
Impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR-positive/HER2-negative breast cancer: a single-center prospective observational study.
Corti C, Chu X, Exman P, Kline DM, et al · · 2025 · cited 2× · PMID 40714511 · DOI 10.1016/j.esmoop.2025.105521
Verify or expand the search:
- PubMed search for NCT03749421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03749421 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
- Last refreshed: 6 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03749421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing