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New study tracks breast cancer return in patients on targeted therapy

NCT ID NCT07180693

Knowledge-focused Sponsor: European Institute of Oncology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study observes 750 people with a common type of breast cancer who have already been treated with surgery and are now taking CDK4/6 inhibitors to lower the risk of cancer coming back. Researchers will track how many patients experience a relapse and how well they do over time. The goal is to better understand the characteristics and outcomes of these patients in real-world settings, which may help improve future treatment decisions.

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 750 people

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

Started

Sep 2025

Expected to finish

Aug 2030

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

All patients diagnosed with HR+/HER2- breast cancer who have received medical treatment in the neoadjuvant or adjuvant setting (chemotherapy, radiotherapy and hormonotherapy) and who have received or are scheduled to initiate adjuvant treatment with CDK4/6 inhibitors (abemaciclib or ribociclib) in combination with ET in the adjuvant setting.

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: * Female (regardless of menopausal status) or male ≥18 years of age; * The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib); * ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations; * Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * Consent to data treatment according to the local regulation. Exclusion Criteria: * Current participation in any other HR+/HER2- EBC study with any investigational products; * Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial; * Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study; * Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago; * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

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

Adjuvant therapy CDK4/6 inhibitor

How to take part

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

  1. The places running it

    18 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

  • ASST Lecco - PO Alessandro Manzoni

    NOT_YET_RECRUITING

    Lecco, Italy, 23900, Italy

  • ASST Ospedale Maggiore di Crema

    RECRUITING

    Crema, Italy, 26013, Italy

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, Italy, 24127, Italy

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy, 25123, Italy

  • Asst Ovest Milanese

    NOT_YET_RECRUITING

    Legnano, Italy, 20025, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    NOT_YET_RECRUITING

    Modena, Italy, 41125, Italy

  • Azienda USL IRCCS di Reggio Emilia

    RECRUITING

    Reggio Emilia, Italy, 42122, Italy

  • European Institute of Oncology

    RECRUITING

    Milan, Italy, 20141, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    NOT_YET_RECRUITING

    Milan, Italy, 20133, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Italy, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Italy, 00168, Italy

  • ICS Maugeri IRCCS

    RECRUITING

    Pavia, Italy, 27100, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy, 20132, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    RECRUITING

    Naples, Italy, 80131, Italy

  • Ospedale Isola Tiberina - Gemelli Isola

    RECRUITING

    Roma, Italy, 00186, Italy

  • P.O. Antonio Perrino - ASL Brindisi

    NOT_YET_RECRUITING

    Brindisi, Italy, 72100, Italy

  • PO Luigi Sacco - ASST Fatebenefratelli Sacco

    RECRUITING

    Milan, Italy, 20157, Italy

  • Policlinico San Matteo

    RECRUITING

    Pavia, Italy, 27100, Italy

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