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A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945927
Collaborator
(none)
500
Enrollment
20.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trastuzumab emtansine

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer
Anticipated Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Participants with HER2-positive Advanced Breast Cancer

Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.

Drug: Trastuzumab emtansine
Trastuzumab emtansine will be administered as per local clinical practice and local labeling.
Other Names:
  • T-DM1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Adverse Events [Up to approximately 1 year from index date]

    Secondary Outcome Measures

    1. Real-world Progression Free Survival (rwPFS) [From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date)]

    2. Time-to-treatment Discontinuation (TTD) [Up to approximately 1 year from index date]

    3. Percentage of Participants Exposed to T-DM1 by Line of Therapy [Up to approximately 1 year from index date]

    4. Percentage of Participants Exposed to T-DM1 by Dosage [Up to approximately 1 year from index date]

    5. Percentage of Participants Exposed to T-DM1 by Dose Intensity [Up to approximately 1 year from index date]

    6. Percentage of Participants Exposed to T-DM1 by Duration [Up to approximately 1 year from index date]

    7. Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System [Up to approximately 1 year from index date]

    8. Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA) [Up to approximately 1 year from index date]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment

    • Had prior treatment for breast cancer which must contain a taxane and trastuzumab

    • Get the treatment of T-DM1 for the first time after diagnosis of breast cancer

    Exclusion Criteria:

    • Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling

    • Has been previously treated with T-DM1 before current clinical visit

    • Currently participating in any clinical trials

    • Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT05945927
    Other Study ID Numbers:
    • ML44675
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Trastuzumab
    Ado-Trastuzumab Emtansine
    Maytansine

    Study Results

    No Results Posted as of Jul 14, 2023