Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03749421

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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 individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look 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.

Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.

Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.

This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prosigna PAM-50 assay

Other

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

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

    Time frame: 2 years

    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

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

    Time frame: 2 years

    The association of the Prosigna test results to pathologic outcomes will be explored marginally in all patients who receive neoadjuvant treatment, and non-parametric Wilcoxon rank sum and Spearman test of correlation with two-sided alpha = 0.05 will be used to make inferences. Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes of response to neoadjuvant treatment.

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

    Time frame: 2 years

    Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes and response to neoadjuvant treatment. On the "Post-Prosigna Physician Questionnaire" physicians will be asked which of these item (ROR score, instrinsic subtype, or both) contributed to their neoadjuvant treatment decision-making.

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

    Time frame: 2 years

    Physicians will complete pre-test and post-test questionnaires that measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of physicians who are confident about their treatment recommendation. The same questions about confidence in diagnosis and treatment will be realized after Prosigna results and rates will be compared.

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

    Time frame: 2 years

    Patients will complete pre-test and post-test questionnaires to measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of patients who understand their diagnosis and how Prosigna works and who are confident in treatment recommendation. The same question about diagnosis and treatment will be realized after Prosigna results and rates will be compared.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • NanoString Technologies, Inc.

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Nov 21, 2018
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.