An Observational Study of Kadcyla Safety in Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02305641
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Study Start: 2015-05-21
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

Inclusion Criteria

• Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.

Exclusion Criteria

• Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
• A pediatric patient (age ≤18 years)
• Hypersensitivity for Kadcyla or any ingredient in this product

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs	Up to 8 years

Secondary Outcome Measures

Name	Time	Method
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)	Up to 8 years

Trial Locations

Locations (38)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

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