An Observational Study of Herceptin SC Safety in Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT02305628
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- All patients administered Herceptin SC for the locally approved indications
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST) Up to 6 years Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC) Up to 6 years
Trial Locations
- Locations (23)
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Ajou University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Wonkwang University School of Medicine & Hospital
🇰🇷Jeonlabuk-do, Korea, Republic of
ChungAng University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Inje University, Sanggye-Paik Hospital
🇰🇷Seoul, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Miz Medi Hospital
🇰🇷Seoul, Korea, Republic of
Myongji Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Borame Medical Center
🇰🇷Seoul, Korea, Republic of