Tucatinib with trastuzumab and capecitabine for HER2‑positive metastatic breast cancer in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, non‑interventional observational study enrolling about 300 patients treated with tucatinib plus trastuzumab and capecitabine according to local label and routine clinical practice. Treating clinicians manage patients with no additional study‑mandated procedures, and baseline data including ECOG performance status, safety, response, and survival are collected. Effectiveness is recorded by investigator‑defined best response and symptomatic benefit, and safety is monitored during treatment and an 18‑month post‑treatment follow‑up. Previous and subsequent non‑tucatinib therapies will also be documented to reflect real‑world treatment patterns.

Why it matters

Who can join: the full rules

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.

Where it's running

• AORN S.G. Moscati
  Avellino, Av, Italy Recruiting
• IRCCS Centro di Riferimento Oncologico (CRO)
  Aviano, Italy Recruiting
• IRCCS Istituto Tumori "Giovanni Paolo II"
  Bari, Italy Recruiting
• ASST Papa Giovanni XXIII
  Bergamo, Italy Recruiting
• AORN "Sant'Anna e San Sebastiano" Caserta
  Caserta, Italy Recruiting
• IRCCS Ospedale San Raffaele
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Michelino De Laurentiis MD
• Email: m.delaurentiis@istitutotumori.na.it
• Phone: 08117770442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.