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.

NCT06272799 | Recruiting

• 1 other identifier: RS1480/21
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the effectiveness of treatment.

  24 months

Study Arms (2)

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

Prospectively cohort

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

Drug: T-DM1 adjuvant

Interventions

T-DM1 adjuvant DRUG

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; Retrospective cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2 positive breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Patrizia Vici, Doctor

CONTACT

+39 06-5266.5698; patrizia.vici@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: September 20, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)