Trials / Recruiting
RecruitingNCT06272799
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.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (estimated)
- Sponsor
- Regina Elena Cancer Institute · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | T-DM1 adjuvant | Evaluate the tolerability of treatment with adjuvant T-DM1 after failure to respond complete pathology to neoadjuvant treatment in terms of adverse events |
Timeline
- Start date
- 2022-09-20
- Primary completion
- 2024-09-20
- Completion
- 2024-09-20
- First posted
- 2024-02-22
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06272799. Inclusion in this directory is not an endorsement.