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

N/ACompletedNCT05945927

Hoffmann-La Roche178 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

178

Conditions

Interventions

Trastuzumab emtansineDRUG

Trastuzumab emtansine will be administered as per local clinical practice and local labeling.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

Percentage of Participants with Adverse Events

Time frame: Up to approximately 1 year from index date

Secondary Outcomes

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)

Time-to-treatment Discontinuation (TTD)

Time frame: Up to approximately 1 year from index date

Percentage of Participants Exposed to T-DM1 by Line of Therapy

Time frame: Up to approximately 1 year from index date

Percentage of Participants Exposed to T-DM1 by Dosage

Time frame: Up to approximately 1 year from index date

Percentage of Participants Exposed to T-DM1 by Dose Intensity

Time frame: Up to approximately 1 year from index date

Percentage of Participants Exposed to T-DM1 by Duration

Time frame: 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

Time frame: 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)

Time frame: Up to approximately 1 year from index date

Data from ClinicalTrials.gov

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NCT05945927 - A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer | Crick | Crick