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

Sponsor

Consorzio Oncotech (Other)

Overall Status

Recruiting

CT.gov ID

NCT05754502

Collaborator

Roche Pharma AG (Industry)

300

Enrollment

Locations

45.2

Anticipated Duration (Months)

10.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Trastuzumab emtansine

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Other

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

Actual Study Start Date :

Jul 27, 2021

Anticipated Primary Completion Date :

Sep 21, 2024

Anticipated Study Completion Date :

May 2, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuovo ospedale di Prato - S. Stefano	Prato	Firenze	Italy	59100
2	A.O.U. Ospedali Riuniti Umberto I	Ancona		Italy	60020
3	IRCCS Istituto Tumori "Giovanni Paolo II"	Bari		Italy
4	Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica	Catania		Italy	95126
5	Azienda Ospedaliera Istituti Ospitalieri di Cremona	Cremona		Italy	26100
6	I.R.C.C.S. A.O.U San Martino - IST	Genova		Italy
7	ASST Lecco - P.O. "A. Manzoni"	Lecco		Italy
8	Istituto Europeo di Oncologia	Milano		Italy	20141
9	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy
10	A.O.U Policlinico di Modena	Modena		Italy
11	Azienda Ospedaliera dei Colli - P.Monaldi	Napoli		Italy	80131
12	Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica	Napoli		Italy	80131
13	Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia	Napoli		Italy	80131
14	A.O.R.N. "A. Cardarelli"	Napoli		Italy
15	A.O.U. 'Maggiore della Carità'	Novara		Italy
16	Istituto Oncologico Veneto IRCCS	Padova		Italy
17	Azienda Ospedaliera Universitaria di Parma - Oncologia Medica	Parma		Italy	43126
18	Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II	Pavia		Italy	27100
19	A. O. U. Pisana - Ospedale S. Chiara	Pisa		Italy
20	IRCCS Arcispedale S.Maria Nuova	Reggio Emilia		Italy
21	Ospedale Sandro Pertini - ASL Roma 2	Roma		Italy	00157
22	Fondazione Policlinico A. Gemelli	Roma		Italy	00168
23	Fondazione Policlinico Gemelli	Roma		Italy
24	Policlinico Universitario Campus Biomedico	Roma		Italy
25	Istituto Clinico Humanitas Irccs	Rozzano		Italy
26	Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia	Salerno		Italy	84131
27	Ospedale Santa Chiara	Trento		Italy
28	ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi	Varese		Italy	21100

Sponsors and Collaborators

Consorzio Oncotech
Roche Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Consorzio Oncotech

ClinicalTrials.gov Identifier:

NCT05754502

Other Study ID Numbers:

GIM26-TRASTHER

First Posted:

Mar 3, 2023

Last Update Posted:

Mar 3, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Trastuzumab

Ado-Trastuzumab Emtansine

Maytansine

Study Results

No Results Posted as of Mar 3, 2023