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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

Recruitingn/aAges 18 Years - anyFemaleFondazione Oncotech
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

30 sites
AORN S.G. Moscati
Avellino, Italy
AOU delle Marche
Ancona, Italy
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
Mons. Dimiccoli P.O. Barletta
Barletta, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
AORN "Sant'Anna e San Sebastiano" Caserta
Caserta, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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