Clinical trial · Observational
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.
NCT06272799CI-TRIAL-00080647ATDrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-DM1 adjuvant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- 80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized
- interventionNames
- Drug: T-DM1 adjuvant
- label
- Prospectively cohort
- description
- Additional 80 patients who meet the inclusion criteria will be enrolled prospectively
- interventionNames
- Drug: T-DM1 adjuvant
Primary outcomes (1)
- measure
- Evaluate the tolerability.
- timeFrame
- 24 months
- description
- 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"
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.