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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754502
• Other study ID #: GIM26-TRASTHER
• Status: Recruiting
• Start date: July 27, 2021
• Est. completion date: May 2, 2025

Study information

• Verified date: February 2023
• Source: Consorzio Oncotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2, 2025
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab emtansine
observational 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.

Locations

Country	Name	City	State
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	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Istituto Europeo di Oncologia	Milano
Italy	A.O.U Policlinico di Modena	Modena
Italy	A.O.R.N. "A. Cardarelli"	Napoli
Italy	Azienda Ospedaliera dei Colli - P.Monaldi	Napoli
Italy	Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica	Napoli
Italy	Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia	Napoli
Italy	A.O.U. 'Maggiore della Carità'	Novara
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Azienda Ospedaliera Universitaria di Parma - Oncologia Medica	Parma
Italy	Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II	Pavia
Italy	A. O. U. Pisana - Ospedale S. Chiara	Pisa
Italy	Nuovo ospedale di Prato - S. Stefano	Prato	Firenze
Italy	IRCCS Arcispedale S.Maria Nuova	Reggio Emilia
Italy	Fondazione Policlinico A. Gemelli	Roma
Italy	Fondazione Policlinico Gemelli	Roma
Italy	Ospedale Sandro Pertini - ASL Roma 2	Roma
Italy	Policlinico Universitario Campus Biomedico	Roma
Italy	Istituto Clinico Humanitas Irccs	Rozzano
Italy	Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia	Salerno
Italy	Ospedale Santa Chiara	Trento
Italy	ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi	Varese

Sponsors (2)

Lead Sponsor	Collaborator
Consorzio Oncotech	Roche Pharma AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response-Effectiveness of treatment with T-DM1	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	up to 36 months