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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab emtansine

• Registration Number: NCT05945927
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-14
• Study Start: 2023-09-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with HER2-positive Advanced Breast Cancer	Trastuzumab emtansine	Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	Up to approximately 1 year from index date

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Exposed to T-DM1 by Dose Intensity	Up to approximately 1 year from index date
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
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
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)
Time-to-treatment Discontinuation (TTD)	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Dosage	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Duration	Up to approximately 1 year from index date
Percentage of Participants Exposed to T-DM1 by Line of Therapy	Up to approximately 1 year from index date

Trial Locations

Locations (30)

Beijing Hospital; 🇨🇳 Beijing, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou City, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, China

Union Hospital of Tongji Medical College, Dept. of Cancer Center; 🇨🇳 Wuhan, China

Anyang Tumor Hosptial; 🇨🇳 Anyang City, China

Affiliated Hospital of Hebei University; 🇨🇳 Baoding, China

Cancer Hospital Chinese Academy of Medical Sciences.; 🇨🇳 Beijing, China

the First Hospital of Jilin University; 🇨🇳 Changchun, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu City, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China

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