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Gene test could help doctors pick best Pre-Surgery breast cancer treatment

NCT ID NCT03749421

Knowledge-focused Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a gene test called Prosigna can help doctors choose the best treatment for women with a common type of breast cancer (HR+/HER2-) before surgery. About 60 women will have their treatment decisions recorded before and after the test results. The goal is to see if the test changes what treatment is recommended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prosigna PAM-50 gene test
What this could lead to
If successful, this could show that a gene test helps personalize breast cancer treatment before surgery, potentially improving outcomes.
What could go wrong
This is a small, early study (60 people) that only measures if doctors change their minds, not if patients actually do better. The test may not improve survival or reduce side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.