Breast Cancer
Conditions
Brief 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.
Interventions
DRUGT-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
Sponsors
Regina Elena Cancer Institute
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the tolerability. | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of treatment. | 24 months | Evaluate in the real life setting the effectiveness of adjuvant treatment in terms of survival free from disease (Disease Free Survival, DFS) in patients with HER2 positive breast cancer and residual invasive disease (on T and/or on N) after neoadjuvant chemotherapy. |
Countries
Italy
Contacts
Primary ContactPatrizia Vici, Doctor
Outcome results
None listed