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

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: T-DM1 adjuvant

• Registration Number: NCT06272799
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2022-09-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospectively cohort	T-DM1 adjuvant	Additional 80 patients who meet the inclusion criteria will be enrolled prospectively
Retrospective cohort	T-DM1 adjuvant	80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy