Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Up to approximately 1 year from index date
Secondary outcomes:
measure: Real-world Progression Free Survival (rwPFS)
timeFrame: 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)
measure: Time-to-treatment Discontinuation (TTD)
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to T-DM1 by Line of Therapy
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to T-DM1 by Dosage
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to T-DM1 by Dose Intensity
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to T-DM1 by Duration
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System
timeFrame: Up to approximately 1 year from index date
measure: Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA)
timeFrame: Up to approximately 1 year from index date
Other outcomes:
Locations:
city: Anyang City
country: China
facility: Anyang Tumor Hosptial
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Chengdu City
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou City
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guiyang
country: China
facility: The Affiliated Cancer Hospital of Guizhou Medical University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei City
country: China
facility: Anhui Province Cancer Hospital
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
city: Jinan City
country: China
facility: The First Affiliated Hospital Of Shandong First Medical University
city: Jinhua
country: China
facility: Dongyang People's Hospital
city: Nanchang City
country: China
facility: The Third Hospital of Nanchang
city: Nanjing
country: China
facility: Nanjing Gulou Hospital
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
city: Shenyang City
country: China
facility: China Medical University (CMU) First Affiliated Hospital
city: Shenzhen City
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Urumqi City
country: China
facility: Cancer Hospital Affliated to Xinjiang Medical University
city: Weifang City
country: China
facility: Weifang People's Hospital
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Yibin
country: China
facility: Yibin Second People's Hospital
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: