An Observational Study of Herceptin SC Safety in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305628
• Other study ID #: ML29625
• Status: Completed
• Start date: June 26, 2015
• Est. completion date: January 31, 2020

Study information

• Verified date: November 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients administered Herceptin SC for the locally approved indications

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Ajou University Medical Center	Gyeonggi-do
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Myongji Hospital	Gyeonggi-do
Korea, Republic of	Gyeongsang National University Hospital	Gyeongsangnam-do
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Wonkwang University School of Medicine & Hospital	Jeonlabuk-do
Korea, Republic of	Borame Medical Center	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	ChungAng University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Inje University, Sanggye-Paik Hospital	Seoul
Korea, Republic of	Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Miz Medi Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hosiptal	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs		Up to 6 years
Secondary	Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)		Up to 6 years
Secondary	Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)		Up to 6 years