Home › Trials › NCT07583485

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

Non-interventional, Multicentric, Prospective, Observational Study to Describe the Effectiveness of Tucatinib in Combination With Capecitabine and Trastuzumab in the Treatment of Metastatic HER-2 Positive Breast Cancer Patients in Real World Setting

Observational Fondazione Oncotech · NCT07583485

This project will see if tucatinib combined with trastuzumab and capecitabine works and is safe for people with HER2‑positive metastatic breast cancer who have had at least two prior anti‑HER2 treatments.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years and up
SexFemale
SponsorFondazione Oncotech Academic / other
Drugs / interventionstrastuzumab, tucatinib, pertuzumab
Locations30 sites (Avellino, AV and 29 other locations)
Trial IDNCT07583485 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18 or older with HER2‑positive metastatic breast cancer who are eligible for tucatinib per local label, have received at least two prior anti‑HER2 therapies, and can provide informed consent.

Not a fit: Patients without radiological assessments, those with significant uncontrolled medical conditions, or those who do not meet the local label or data requirements are unlikely to benefit from the study's findings.

Why it matters

Potential benefit: If results are favorable, they could support that this combination is effective and safe in everyday clinical practice and help guide treatment decisions for heavily pretreated HER2‑positive patients.

How similar studies have performed: Randomized trials such as HER2CLIMB have shown that tucatinib combined with trastuzumab and capecitabine improves outcomes, so this observational study aims to document how that regimen performs in routine care.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Avellino, AV and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.