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Breast CancerNCT05754502

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

An observational study of Breast Cancer, run by Consorzio Oncotech at 28 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab emtansine
How many people
300 participants
Where
28 sitesItaly
Study dates
27 Jul 2021to 2 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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;

Who cannot join

  • NA

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Italy28 sites, 28 recruiting

  • A.O.U. Ospedali Riuniti Umberto I

    Ancona, 60020

    Rossana Berardi, MD, 0715965715, rossana.berardi@ospedaliriuniti.marche.it

    Stefano Cascinu, MD

    Recruiting

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    Bari

    Lucia Rinaldi, 0805555143, l.rinaldi@oncologico.bari.it

    Recruiting

  • Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica

    Catania, 95126

    Maria Vita Sanò, 09573390199, maria_vita.sano@ccocatania.it

    Recruiting

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 26100

    Daniele Generali, +390372408042, daniele.generali@asst-cremona.it

    Daniele Generali, MD

    Recruiting

  • I.R.C.C.S. A.O.U San Martino - IST

    Genova

    Lucia Del Mastro, MD, 0105558908, lucia.delmastro@hsanmartino.it

    Lucia Del Mastro, MD

    Recruiting

  • ASST Lecco - P.O. "A. Manzoni"

    Lecco

    Alessandra Crippa, 0341489900, a.crippa@asst-lecco.it

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Giuseppe Cancello, 02/57489970, giuseppe.cancello@ieo.it

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Giulia Valeria Bianchi, MD, 0223902286, giulia.bianchi@istitutotumori.mi.it

    Recruiting

  • A.O.U Policlinico di Modena

    Modena

    Federico Piacentini, 0594223221, federico.piacentini@unimore.it

    Recruiting

  • Azienda Ospedaliera dei Colli - P.Monaldi

    Naples, 80131

    Vincenzo Montesarchio, MD, +390817065286, dott.vincenzomontesarchio@gmail.com

    Vincenzo Montesarchio, MD

    Recruiting

  • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica

    Naples, 80131

    Michelino De Laurentiis, 0815903699, m.delaurentiis@istitutotumori.na.it

    MICHELINO DE LAURENTIIS, Md

    Recruiting

  • Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia

    Naples, 80131

    Sabino De Placido, 0817463660, deplacid@unina.it

    SABINO DE PLACIDO, Md

    Recruiting

  • A.O.R.N. "A. Cardarelli"

    Naples

    Ferdinando Riccardi, 081/7472223, ferdinando.riccardi@aocardarelli.it

    Recruiting

  • A.O.U. 'Maggiore della Carità'

    Novara

    Alessandra Gennari, 03213733822, alessandra.gennari@uniupo.it

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova

    Valentina Guarneri, 0498215931, valentina.guarneri@unipd.it

    Recruiting

  • Azienda Ospedaliera Universitaria di Parma - Oncologia Medica

    Parma, 43126

    ANTONIO MUSOLINO, 0521702660, amusolino@ao.pr.it

    ANTONIO MUSOLINO, MD

    Recruiting

  • Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II

    Pavia, 27100

    Antonio Bernardo, 0382592204, antonio.bernardo@icsmaugeri.it

    ANTONIO BERNARDO, Md

    Recruiting

  • A. O. U. Pisana - Ospedale S. Chiara

    Pisa

    Andrea Fontana, 3334139529, AN.FONTANA@AO-PISA.TOSCANA.IT

    Recruiting

  • Nuovo ospedale di Prato - S. Stefano

    Prato, Firenze, 59100

    Erica Moretti, MD, 0574802520, erica.moretti@uslcentro.toscana.it

    Giuseppina Sanna, MD

    Recruiting

  • IRCCS Arcispedale S.Maria Nuova

    Reggio Emilia

    Giancarlo Bisagni, 0522296858, giancarlo.bisagni@ausl.re.it

    Recruiting

  • Ospedale Sandro Pertini - ASL Roma 2

    Roma, 00157

    Giuliana D'Auria, 0641431, giuliana.dauria@aslroma2.it

    Recruiting

  • Fondazione Policlinico A. Gemelli

    Roma, 00168

    Ida Paris, 0630158545, ida.paris@policlinicogemelli.it

    Recruiting

  • Fondazione Policlinico Gemelli

    Roma

    Fabio Marazzi, 0630155887, fabio.marazzi@policlinicogemelli.it

    Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma

    Giuseppe Tonini, 06225418855, g.tonini@unicampus.it

    Recruiting

  • Istituto Clinico Humanitas Irccs

    Rozzano

    Rosalba Torrisi, 0282245918, rosalba.torrisi@cancercenter.humanitas.it

    Recruiting

  • Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia

    Salerno, 84131

    Clementina Savastano, 089672528, clementina.savastano@sangiovannieruggi.it

    CLEMENTINA SAVASTANO, Md

    Recruiting

  • Ospedale Santa Chiara

    Trento

    Antonella Ferro, 0461902121, antonella.ferro@apss.tn.it

    Recruiting

  • ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi

    Varese, 21100

    Elisa Gallerani, 0332278558, elisa.gallerani@asst-settelaghi.it

    Recruiting

Other trials in Italy

About this study

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.

Conditions
Breast Cancer
Being tested
Trastuzumab emtansine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab emtansineDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start27 Jul 2021
  3. Primary completion21 Sep 2024 (estimated)
  4. Study completion2 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754502
Sponsor's protocol ID
GIM26-TRASTHER
Status last verified
Feb 2023
First submitted
21 Feb 2023
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Consorzio Oncotech at 28 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response-Effectiveness of treatment with T-DM1 (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05754502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

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