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
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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;
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Nuovo ospedale di Prato - S. Stefano
🇮🇹Prato, Firenze, Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
🇮🇹Bari, Italy
A.O.U. Ospedali Riuniti Umberto I
🇮🇹Ancona, 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
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
ASST Lecco - P.O. "A. Manzoni"
🇮🇹Lecco, 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.R.N. "A. Cardarelli"
🇮🇹Napoli, Italy
A.O.U. 'Maggiore della Carità'
🇮🇹Novara, Italy
A. O. U. Pisana - Ospedale S. Chiara
🇮🇹Pisa, 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
IRCCS Arcispedale S.Maria Nuova
🇮🇹Reggio Emilia, Italy
Fondazione Policlinico A. Gemelli
🇮🇹Roma, Italy
Ospedale Sandro Pertini - ASL Roma 2
🇮🇹Roma, Italy
Fondazione Policlinico Gemelli
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
🇮🇹Salerno, Italy
Istituto Clinico Humanitas Irccs
🇮🇹Rozzano, Italy
Ospedale Santa Chiara
🇮🇹Trento, Italy
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
A.O.U Policlinico di Modena
🇮🇹Modena, Italy