Clinical trial · Observational
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
NCT03749421CI-TRIAL-00102642active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prosigna PAM-50 assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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).
- interventionNames
- Other: Prosigna PAM-50 assay
Primary outcomes (1)
- measure
- The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
- timeFrame
- 2 years
- description
- Questionnaires will be used to record neoadjuvant treatment decisions pre- and post-test. Data will be summarized in a contingency table, and the extent to which decisions changed will be estimated as the proportion of discordant responses and reported with a two-sided exact 95% confidence interval.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCorti C, Chu X, Exman P, Kline DM, Priedigkeit NM, Mayer EL, Waks AG, Hughes ME, Abravanel DL, Giordano A, Curigliano G, Lin NU, King TA, Jeselsohn RM, Manning DK, Dillon DA, Mittendorf EA, Tayob N, Tolaney SM. 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. ESMO Open. 2025 Aug;10(8):105521. doi: 10.1016/j.esmoop.2025.105521. Epub 2025 Jul 25. PMID 40714511