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.
Recruiting · NCT06272799 · Observational (researchers observe without assigning treatment) · Lead sponsor: Regina Elena Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
T-DM1 adjuvant
What this trial is about
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 take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 objectives;
- Patients with a history of other malignant neoplasms;
- Contraindications to the use of T-DM
Where it is running
1 location listed.
- "Regina Elena" National Cancer Institute - Rome, Rome, Italy