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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05945927
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : May 23, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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
Breast Cancer Drug: Trastuzumab emtansine

Study Design
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Study Type : Observational
Estimated 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
Actual Study Start Date : September 13, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort 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 Name: T-DM1


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 1 year from index date ]

Secondary Outcome Measures :
  1. Real-world Progression Free Survival (rwPFS) [ Time Frame: 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) [ Time Frame: Up to approximately 1 year from index date ]
  3. Percentage of Participants Exposed to T-DM1 by Line of Therapy [ Time Frame: Up to approximately 1 year from index date ]
  4. Percentage of Participants Exposed to T-DM1 by Dosage [ Time Frame: Up to approximately 1 year from index date ]
  5. Percentage of Participants Exposed to T-DM1 by Dose Intensity [ Time Frame: Up to approximately 1 year from index date ]
  6. Percentage of Participants Exposed to T-DM1 by Duration [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to approximately 1 year from index date ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945927


Contacts
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Contact: Reference Study ID Number: ML44675 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05945927    
Other Study ID Numbers: ML44675
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: May 23, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs