Condition: Breast Cancer · Sponsor: Fondazione Oncotech
Non-interventional, multicenter, prospective observational study of tucatinib-trastuzumab capecitabine administered according to the standard local clinical practice following approved SmPC indication and dose. About 300 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. Primary Objective: To assess the treatment safety and effectiveness as measured by investigator criteria in metastatic breast cancer patients within the real-world setting treated with tucatinib in combination with trastuzumab and capecitabine according to standard local clinical practice following approved Summary of Product Characteristics (SmPC) indication and dose. The primary purpose of this study is to evaluate the real word effectiveness of the combination therapy "tucatinib/trastuzumab/capecitabine" in mBC patients according to the approved SmPC indication and dose in the real-world setting. Patients with human epidermal growth factor receptor 2 (HER2)- positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. HER2 is a transmembrane tyrosine kinase receptor that mediates cell growth, differentiation, and survival. HER2 is overexpressed in approximately 20% of breast cancers. Both antibody and small-molecule drug…
This description comes directly from the study's public registry record.
Michelino De Laurentiis MD · 08117770442 · m.delaurentiis@istitutotumori.na.it
Always discuss trial participation with your own doctor first.
| AORN S.G. Moscati | Avellino, AV, Italy | Recruiting |
| AOU delle Marche | Ancona, Italy | Active Not Recruiting |
| IRCCS Centro di Riferimento Oncologico (CRO) | Aviano, Italy | Recruiting |
| IRCCS Istituto Tumori "Giovanni Paolo II" | Bari, Italy | Recruiting |
| Mons. Dimiccoli P.O. Barletta | Barletta, Italy | Not Yet Recruiting |
| ASST Papa Giovanni XXIII | Bergamo, Italy | Recruiting |
| AORN "Sant'Anna e San Sebastiano" Caserta | Caserta, Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genova, Italy | Active Not Recruiting |
| IRCCS Ospedale San Raffaele | Milan, Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan, Italy | Recruiting |
| Humanitas Istituto Clinico Catanese | Misterbianco, Italy | Recruiting |
| A.O. "A. Cardarelli" | Naples, Italy | Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07583485