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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-DM1 adjuvant.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Evaluate the tolerability. [Time frame: 24 months]
Secondary outcome measures (1)
- Evaluate the effectiveness of treatment. [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- "Regina Elena" National Cancer Institute — Rome
Identifiers
NCT: NCT06272799 · RS1480/21