Trial 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
NCT ID:
NCT05754502
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab emtansine
Description:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nuovo ospedale di Prato - S. Stefano
Address:
City:
Prato
Zip:
59100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Erica Moretti, MD
Phone:
0574802520
Email:
erica.moretti@uslcentro.toscana.it
Investigator:
Last name:
Giuseppina Sanna, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Ospedali Riuniti Umberto I
Address:
City:
Ancona
Zip:
60020
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rossana Berardi, MD
Phone:
0715965715
Email:
rossana.berardi@ospedaliriuniti.marche.it
Investigator:
Last name:
Stefano Cascinu, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Tumori "Giovanni Paolo II"
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lucia Rinaldi
Phone:
0805555143
Email:
l.rinaldi@oncologico.bari.it
Facility:
Name:
Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
Address:
City:
Catania
Zip:
95126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Vita Sanò
Phone:
09573390199
Email:
maria_vita.sano@ccocatania.it
Facility:
Name:
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Address:
City:
Cremona
Zip:
26100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniele Generali
Phone:
+390372408042
Email:
daniele.generali@asst-cremona.it
Investigator:
Last name:
Daniele Generali, MD
Email:
Principal Investigator
Facility:
Name:
I.R.C.C.S. A.O.U San Martino - IST
Address:
City:
Genova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lucia Del Mastro, MD
Phone:
0105558908
Email:
lucia.delmastro@hsanmartino.it
Investigator:
Last name:
Lucia Del Mastro, MD
Email:
Principal Investigator
Facility:
Name:
ASST Lecco - P.O. "A. Manzoni"
Address:
City:
Lecco
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Crippa
Phone:
0341489900
Email:
a.crippa@asst-lecco.it
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Cancello
Phone:
02/57489970
Email:
giuseppe.cancello@ieo.it
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giulia Valeria Bianchi, MD
Phone:
0223902286
Email:
giulia.bianchi@istitutotumori.mi.it
Facility:
Name:
A.O.U Policlinico di Modena
Address:
City:
Modena
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federico Piacentini
Phone:
0594223221
Email:
federico.piacentini@unimore.it
Facility:
Name:
Azienda Ospedaliera dei Colli - P.Monaldi
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vincenzo Montesarchio, MD
Phone:
+390817065286
Email:
dott.vincenzomontesarchio@gmail.com
Investigator:
Last name:
Vincenzo Montesarchio, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michelino De Laurentiis
Phone:
0815903699
Email:
m.delaurentiis@istitutotumori.na.it
Investigator:
Last name:
MICHELINO DE LAURENTIIS, Md
Email:
Principal Investigator
Facility:
Name:
Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sabino De Placido
Phone:
0817463660
Email:
deplacid@unina.it
Investigator:
Last name:
SABINO DE PLACIDO, Md
Email:
Principal Investigator
Facility:
Name:
A.O.R.N. "A. Cardarelli"
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ferdinando Riccardi
Phone:
081/7472223
Email:
ferdinando.riccardi@aocardarelli.it
Facility:
Name:
A.O.U. 'Maggiore della Carità'
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Gennari
Phone:
03213733822
Email:
alessandra.gennari@uniupo.it
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Valentina Guarneri
Phone:
0498215931
Email:
valentina.guarneri@unipd.it
Facility:
Name:
Azienda Ospedaliera Universitaria di Parma - Oncologia Medica
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
ANTONIO MUSOLINO
Phone:
0521702660
Email:
amusolino@ao.pr.it
Investigator:
Last name:
ANTONIO MUSOLINO, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Bernardo
Phone:
0382592204
Email:
antonio.bernardo@icsmaugeri.it
Investigator:
Last name:
ANTONIO BERNARDO, Md
Email:
Principal Investigator
Facility:
Name:
A. O. U. Pisana - Ospedale S. Chiara
Address:
City:
Pisa
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Fontana
Phone:
3334139529
Email:
AN.FONTANA@AO-PISA.TOSCANA.IT
Facility:
Name:
IRCCS Arcispedale S.Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giancarlo Bisagni
Phone:
0522296858
Email:
giancarlo.bisagni@ausl.re.it
Facility:
Name:
Ospedale Sandro Pertini - ASL Roma 2
Address:
City:
Roma
Zip:
00157
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuliana D'Auria
Phone:
0641431
Email:
giuliana.dauria@aslroma2.it
Facility:
Name:
Fondazione Policlinico A. Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ida Paris
Phone:
0630158545
Email:
ida.paris@policlinicogemelli.it
Facility:
Name:
Fondazione Policlinico Gemelli
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Marazzi
Phone:
0630155887
Email:
fabio.marazzi@policlinicogemelli.it
Facility:
Name:
Policlinico Universitario Campus Biomedico
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Tonini
Phone:
06225418855
Email:
g.tonini@unicampus.it
Facility:
Name:
Istituto Clinico Humanitas Irccs
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rosalba Torrisi
Phone:
0282245918
Email:
rosalba.torrisi@cancercenter.humanitas.it
Facility:
Name:
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
Address:
City:
Salerno
Zip:
84131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Clementina Savastano
Phone:
089672528
Email:
clementina.savastano@sangiovannieruggi.it
Investigator:
Last name:
CLEMENTINA SAVASTANO, Md
Email:
Principal Investigator
Facility:
Name:
Ospedale Santa Chiara
Address:
City:
Trento
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonella Ferro
Phone:
0461902121
Email:
antonella.ferro@apss.tn.it
Facility:
Name:
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa Gallerani
Phone:
0332278558
Email:
elisa.gallerani@asst-settelaghi.it
Start date:
July 27, 2021
Completion date:
May 2, 2025
Lead sponsor:
Agency:
Consorzio Oncotech
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Consorzio Oncotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754502
