Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05754502
• Lead Sponsor: Consorzio Oncotech

Brief Summary

This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711. During the compassionate use program AL41711, subjects received T-DM1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. After the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. After the signature of the Informed Consent Form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. From the end of the washout period following the last treatment with T-DM1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. This phase will be prospective after the signature of the Informed Consent Form.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03
• Primary Completion: 2024-09-21
• Study Completion: 2025-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Signed written informed consent
• Patients who have received T-DM1 treatment within the compassionate use program AL41711 and have completed the entire treatment for at least 90 days or have interrupted it prematurely, due to disease recurrence or unmanageable toxicity, for at least 90 days, corresponding to the wash out period;

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response-Effectiveness of treatment with T-DM1	up to 36 months	assess the long term effectiveness of treatment with T-DM1 as compassionate use in patients with HER2-positive breast cancer that do not reach a complete response following neoadjuvant chemotherapy and anti-HER2 target therapy

Trial Locations

Locations (28)

Nuovo ospedale di Prato - S. Stefano; 🇮🇹 Prato, Firenze, Italy

A.O.U. Ospedali Riuniti Umberto I; 🇮🇹 Ancona, Italy

IRCCS Istituto Tumori "Giovanni Paolo II"; 🇮🇹 Bari, Italy

Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica; 🇮🇹 Catania, Italy

Azienda Ospedaliera Istituti Ospitalieri di Cremona; 🇮🇹 Cremona, Italy

I.R.C.C.S. A.O.U San Martino - IST; 🇮🇹 Genova, Italy

ASST Lecco - P.O. "A. Manzoni"; 🇮🇹 Lecco, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

A.O.U Policlinico di Modena; 🇮🇹 Modena, Italy

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