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

March 2, 2023 updated by: Consorzio Oncotech
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60020
      • Bari, Italy
      • Catania, Italy, 95126
        • Recruiting
        • Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
        • Contact:
      • Cremona, Italy, 26100
        • Recruiting
        • Azienda Ospedaliera Istituti Ospitalieri di Cremona
        • Principal Investigator:
          • Daniele Generali, MD
        • Contact:
      • Genova, Italy
      • Lecco, Italy
        • Recruiting
        • ASST Lecco - P.O. "A. Manzoni"
        • Contact:
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Contact:
      • Milano, Italy
      • Modena, Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
        • Contact:
      • Napoli, Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera dei Colli - P.Monaldi
      • Napoli, Italy, 80131
        • Recruiting
        • Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
        • Contact:
      • Novara, Italy
      • Padova, Italy
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera Universitaria di Parma - Oncologia Medica
        • Principal Investigator:
          • ANTONIO MUSOLINO, MD
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
        • Contact:
      • Pisa, Italy
      • Reggio Emilia, Italy
      • Roma, Italy
      • Roma, Italy, 00168
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Biomedico
        • Contact:
      • Roma, Italy, 00157
      • Rozzano, Italy
      • Salerno, Italy, 84131
        • Recruiting
        • Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
        • Principal Investigator:
          • CLEMENTINA SAVASTANO, Md
        • Contact:
      • Trento, Italy
      • Varese, Italy, 21100
    • Firenze
      • Prato, Firenze, Italy, 59100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response-Effectiveness of treatment with T-DM1
Time Frame: 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
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Oncotech

Collaborators

Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Anticipated)

September 21, 2024

Study Completion (Anticipated)

May 2, 2025

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM26-TRASTHER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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