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)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: T-DM1 adjuvant

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Patrizia Vici, Doctor; Phone Number: +39 +39 06-5266.5698; Email: patrizia.vici@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Patrizia Vici, Doctor; Phone Number: +39 +39 06-5266.5584; Email: patrizia.vici@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HER2 positive breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective cohort; 80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized	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
Prospectively cohort; Additional 80 patients who meet the inclusion criteria will be enrolled prospectively	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the tolerability.	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"	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of treatment.	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.	24 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RS1480/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No