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
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
"Regina Elena" National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Patrizia Vici, Doctor
patrizia.vici@ifo.it
+39 06-5266.5698
Time Frame
Start Date: 2022-09-20
Estimated Completion Date: 2024-09-20
Participants
Target number of participants: 160
Treatments
Retrospective cohort
80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized
Prospectively cohort
Additional 80 patients who meet the inclusion criteria will be enrolled prospectively
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov