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
1 other identifier
observational
300
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2021
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2025
CompletedMarch 3, 2023
February 1, 2023
3.2 years
February 21, 2023
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
The study will include approximately 300 patients with HER2-positive breast cancer that do not reach a pathological complete response following neoadjuvant chemotherapy and anti-HER2 target therapy and received T-DM1 within the compassionate use program AL41711.
You may qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Consorzio Oncotechlead
- Roche Pharma AGcollaborator
Study Sites (28)
Nuovo ospedale di Prato - S. Stefano
Prato, Firenze, 59100, Italy
A.O.U. Ospedali Riuniti Umberto I
Ancona, 60020, Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
Catania, 95126, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, 26100, 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
Milan, 20141, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
A.O.U Policlinico di Modena
Modena, Italy
Azienda Ospedaliera dei Colli - P.Monaldi
Napoli, 80131, Italy
Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
Napoli, 80131, Italy
Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
Napoli, 80131, Italy
A.O.R.N. "A. Cardarelli"
Napoli, Italy
A.O.U. 'Maggiore della Carità'
Novara, Italy
Istituto Oncologico Veneto IRCCS
Padua, Italy
Azienda Ospedaliera Universitaria di Parma - Oncologia Medica
Parma, 43126, Italy
Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
Pavia, 27100, Italy
A. O. U. Pisana - Ospedale S. Chiara
Pisa, Italy
IRCCS Arcispedale S.Maria Nuova
Reggio Emilia, Italy
Ospedale Sandro Pertini - ASL Roma 2
Roma, 00157, Italy
Fondazione Policlinico A. Gemelli
Roma, 00168, Italy
Fondazione Policlinico Gemelli
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, 84131, Italy
Ospedale Santa Chiara
Trento, Italy
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Varese, 21100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 3, 2023
Study Start
July 27, 2021
Primary Completion
September 21, 2024
Study Completion
May 2, 2025
Last Updated
March 3, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share