Clinical trial NCT05754502: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Consorzio Oncotech
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2023-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete response-Effectiveness of treatment with T-DM1
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Nuovo ospedale di Prato - S. Stefano
state: Firenze
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto I
city: Bari
country: Italy
facility: IRCCS Istituto Tumori "Giovanni Paolo II"
city: Catania
country: Italy
facility: Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
city: Genova
country: Italy
facility: I.R.C.C.S. A.O.U San Martino - IST
city: Lecco
country: Italy
facility: ASST Lecco - P.O. "A. Manzoni"
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Modena
country: Italy
facility: A.O.U Policlinico di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli - P.Monaldi
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
city: Napoli
country: Italy
facility: Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
city: Napoli
country: Italy
facility: A.O.R.N. "A. Cardarelli"
city: Novara
country: Italy
facility: A.O.U. 'Maggiore della Carità'
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria di Parma - Oncologia Medica
city: Pavia
country: Italy
facility: Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
city: Pisa
country: Italy
facility: A. O. U. Pisana - Ospedale S. Chiara
city: Reggio Emilia
country: Italy
facility: IRCCS Arcispedale S.Maria Nuova
city: Roma
country: Italy
facility: Ospedale Sandro Pertini - ASL Roma 2
city: Roma
country: Italy
facility: Fondazione Policlinico A. Gemelli
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Irccs
city: Salerno
country: Italy
facility: Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Varese
country: Italy
facility: ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Study officials:
References: