Observational Study of Tucatinib With Capecitabine and Trastuzumab for Women With Metastatic HER2-Positive Breast Cancer in Real-World Care

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tucatinib combined with trastuzumab and capecitabine in adult women with HER2-positive metastatic breast cancer in a real-world setting. This observational study includes patients who have previously received multiple HER2-targeted treatments and aims to understand how this combination therapy works outside of clinical trials. HER2 is a protein that promotes cancer cell growth and is overexpressed in about 20% of breast cancers. Tucatinib is an oral drug that selectively inhibits the HER2 protein, and this study follows approved treatment guidelines and doses. Patients will receive tucatinib, trastuzumab, and capecitabine as prescribed by their doctors according to local clinical practice without any additional treatment procedures mandated by the study. The study is non-interventional and multicenter, enrolling about 300 women who are candidates for tucatinib therapy, including those with prior treatments such as trastuzumab, pertuzumab, T-DM1, and T-DXd. Patients will be observed during their treatment period and followed for 18 months after finishing tucatinib therapy to monitor outcomes and safety. During the study, researchers will collect baseline data, safety information, and performance status using the Eastern Cooperative Oncology Group ECOG score. They will assess response to treatment and survival based on clinicians evaluations and local practice. Follow-up will include monitoring for symptoms, treatment response, and survival status for 18 months post-treatment. The study also records any treatments patients receive before or after tucatinib therapy to better understand its real-world effectiveness and safety.

GIM27-THERapy: a 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