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.
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.
Regina Elena Cancer Institute
160 participants
Sep 20, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Histological diagnosis of HER2 positive breast cancer;
- Presence of invasive residual disease on T or N after neoadjuvant chemotherapy including anti-HER2 agents
- Treatment with T-DM1 in the adjuvant post-neoadjuvant setting, in case of positive hormone receptors in combination with adjuvant hormone therapy. Complementary radiotherapy will be allowed as per lines guide;
- Availability of adequate information regarding treatment with adjuvant T-DM1 in accordance with the objectives of the study;
- Written informed consent for the prospective part and, if possible, for the recruited patients retrospectively
Exclusion Criteria4
- Concomitant treatments with other biological agents;
- Absence of clinical data that allow the correct analysis of the primary and secondary objectives;
- Patients with a history of other malignant neoplasms;
- Contraindications to the use of T-DM
Interventions
Evaluate the tolerability of treatment with adjuvant T-DM1 after failure to respond complete pathology to neoadjuvant treatment in terms of adverse events
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06272799