NCT03749421

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 the most personalized pre-operative treatment for breast cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2019Dec 2026

First Submitted

Initial submission to the registry

October 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

October 19, 2018

Last Update Submit

February 4, 2026

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    2 years

Secondary Outcomes (4)

  • The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).

    2 years

  • To assess if treatment change was based on ROR score, intrinsic subtype or both

    2 years

  • To evaluate physicians' confidence in their therapy before and after the test

    2 years

  • To evaluate patients' confidence in their therapy before and after the test

    2 years

Study Arms (1)

Prosigna Assay

* 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).

Other: Prosigna PAM-50 assay

Interventions

Prosigna PAM-50 assayOTHER

Looks at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery

Prosigna Assay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that are considered possible candidates for neoadjuvant treatment, irrespective whether chemotherapy or endocrine therapy, by clinical-pathologic features.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Corti 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: 40714511DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sara Tolaney, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2018

First Posted

November 21, 2018

Study Start

March 21, 2019

Primary Completion

November 29, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)