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. (ATD)

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: T-DM1 adjuvant

Study type: Observational

Funder types: Other

Identifiers

NCT06272799

RS1480/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

Retrospective cohort

Description:

80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized

Treatment:

Drug: T-DM1 adjuvant

Prospectively cohort

Description:

Additional 80 patients who meet the inclusion criteria will be enrolled prospectively

Treatment:

Drug: T-DM1 adjuvant