Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer A
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.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | Inclusion Criteria: * 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 Criteria: * Concomitant treatments with other biological agents; * Absence of clinical data that allow the correct analysis of the primary and secondary |
| Sex | Female |
| Lead sponsor | Regina Elena Cancer Institute |
| Locations | Rome, Rome, Italy |
| Start date | 2022-09-20 |
| NCT ID | NCT06272799 |
| Official listing | https://clinicaltrials.gov/study/NCT06272799 |