"Regina Elena" National Cancer Institute
Rome, 00144, Italy
Location status: Recruiting
NCT Number: NCT06272799
Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.
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Observational
Rome, 00144, Italy
Location status: Recruiting
Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluate the tolerability of treatment with adjuvant T-DM1 after failure to respond complete pathology to neoadjuvant treatment in terms of adverse events
Time frame: 24 months
Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, version 4), in a population of patients treated with adjuvant T-DM1 in "real life"
Time frame: 24 months
Evaluate in the "real life setting" the effectiveness of adjuvant treatment in terms of survival free from disease (Disease Free Survival, DFS) in patients with HER2 positive breast cancer and residual invasive disease (on T and/or on N) after neoadjuvant chemotherapy.
Contact information is provided by the study sponsor or research team.
Regina Elena Cancer Institute
Other
Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study. ATD-Study.
Acronym: ATD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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