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New hope for Hard-to-Treat breast cancer: Real-World study launches

NCT ID NCT07583485

Disease control Sponsor: Fondazione Oncotech 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows about 300 women with HER2-positive breast cancer that has spread. They are getting a three-drug combination (tucatinib, capecitabine, trastuzumab) as part of their normal care. The goal is to see how well the treatment works and how safe it is in everyday medical practice, especially for patients who have already tried other anti-HER2 therapies.

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 300 people

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

Started

Jul 2024

Expected to finish

Jul 2029

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

Her2 positive metastatic breast cancer patients who are candidate to tucatinib treatment in real world setting including patients previously treated with trastuzumab, pertuzumab, T-DM1, T-DXd as per authorized therapy setting and NPP/EAP ongoing program.

Ages

18 years and older

Sex

Female participants only

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: * Women aged 18 years or older; * Metastatic breast cancer her2 positive; * Treatment and treated indication according to local label SmPC and reimbursement for tucatinib-trastuzumab capecitabine treatment; * At least 2 prior anti her2 treatment in any setting; * Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study. Exclusion Criteria: * Patients with diseases or significant clinical condition, according to the findings of the investigator, may interfere with the study evaluations; * Absence of any radiological assessment; * No data on tucatinib efficacy and safety.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

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

    26 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

  • A.O. "A. Cardarelli"

    RECRUITING

    Naples, Italy

  • A.O.U. "Città della Salute e della Scienza di Torino" - P.O. Sant'Anna

    NOT_YET_RECRUITING

    Torino, Italy

  • A.O.U. "San Giovanni di Dio e Ruggi d'Aragona"

    NOT_YET_RECRUITING

    Salerno, Italy

  • A.O.U. Policlinico "Umberto I"

    NOT_YET_RECRUITING

    Roma, Italy

  • A.O.U.P. "P. Giaccone"

    ACTIVE_NOT_RECRUITING

    Palermo, Italy

  • A.S.L. Napoli 3 SUD - P.O. Apicella

    NOT_YET_RECRUITING

    Pollena Trocchia, Italy

  • AORN "Sant'Anna e San Sebastiano" Caserta

    RECRUITING

    Caserta, Italy

  • AORN S.G. Moscati

    RECRUITING

    Avellino, AV, Italy

  • AOU Federico II

    ACTIVE_NOT_RECRUITING

    Naples, Italy

  • AOU delle Marche

    ACTIVE_NOT_RECRUITING

    Ancona, Italy

  • ARNAS Civico - Palermo

    NOT_YET_RECRUITING

    Palermo, Italy

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy

  • AUSL della Romagna - IRST-IRCCS "Dino Amadori"

    RECRUITING

    Rimini, Italy

  • Azienda Provinciale Servizi Sanitari di Trento - Ospedale Santa Chiara

    NOT_YET_RECRUITING

    Trento, Italy

  • Casa Sollievo della Sofferenza

    NOT_YET_RECRUITING

    San Giovanni Rotondo, Italy

  • Fondazione Universitaria Policlinico Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Italy

  • Humanitas Istituto Clinico Catanese

    RECRUITING

    Misterbianco, Italy

  • I.R.C.C.S. Istituto Clinico Humanitas

    NOT_YET_RECRUITING

    Rozzano, Italy

  • IRCCS Centro di Riferimento Oncologico (CRO)

    RECRUITING

    Aviano, Italy

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    RECRUITING

    Bari, Italy

  • IRCCS Ospedale Policlinico San Martino

    ACTIVE_NOT_RECRUITING

    Genova, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, Italy

  • Istituto Nazionale Tumori "Fondazione G. Pascale"

    RECRUITING

    Naples, Italy

  • Istituto Oncologico Veneto I.R.C.C.S.

    RECRUITING

    Padova, Italy

  • La Maddalena

    NOT_YET_RECRUITING

    Palermo, Italy

  • Mons. Dimiccoli P.O. Barletta

    NOT_YET_RECRUITING

    Barletta, Italy

  • Ospedale "Guglielmo Da Saliceto"

    RECRUITING

    Piacenza, Italy

  • Ospedale "Sandro Pertini" - A.S.L. Roma 2

    NOT_YET_RECRUITING

    Roma, Italy

  • P.O. "Andrea Tortora"

    NOT_YET_RECRUITING

    Pagani, Italy

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