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New study aims to decode BRCA breast cancer biology for smarter treatment

NCT ID NCT07617025

Knowledge-focused Sponsor: Angela Toss Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will analyze tumor tissue from 100 people with BRCA1 or BRCA2 mutations and HR-positive, HER2-negative breast cancer. Researchers want to see if different molecular subtypes are linked to how well patients respond to hormone therapy or CDK4/6 inhibitors. No extra tests or procedures are needed beyond standard care.

What this could mean

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

What this could lead to
If successful, this study could help doctors better predict which BRCA-related breast cancers may respond to specific treatments like CDK4/6 inhibitors.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test new therapies, and findings may not change care immediately.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

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

Each enrolling center will be responsible for identifying patients eligible for the study. Information will be collected for each patient regarding: * Patient and treatment characteristics: age, date of diagnosis, and data relating to any treatments received. * Biological characteristics of the primary disease: histotype, grade, hormone receptor and HER2 expression, and cytoproliferative activity. The data collected reflect those normally collected in clinical practice for patients diagnosed with breast cancer. No additional specific visits or assessments are required.

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: * Age 18 years or older * Patients carrying a pathogenic or likely pathogenic germline variant in BRCA1 or BRCA2 with a histologically confirmed diagnosis of HR+/HER2-negative breast cancer * Patients with available hospital and/or outpatient medical records for clinical data collection * Presence of available formally fixed paraffin-embedded (FFPE) breast tumor tissue (primary or metastatic site) Exclusion Criteria: * None

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    RECRUITING

    Modena, 41124, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori Milano

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli di Roma

    RECRUITING

    Roma, 00168, Italy

  • Istituto Oncologico Europeo di Milano

    RECRUITING

    Milan, 20141, Italy

  • Istituto Oncologico Veneto IRCCS Padova

    RECRUITING

    Padova, 35128, Italy

  • Ospedale San Martino di Genova

    RECRUITING

    Genova, 16132, Italy

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