An Observational Study of Herceptin SC Safety in Breast Cancer

Completed

• 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

Study Timeline

• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Study Start: 2015-06-26
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• All patients administered Herceptin SC for the locally approved indications

Exclusion Criteria

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)

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

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

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

Myongji Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

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

Ajou University Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Gyeongsangnam-do, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Gyeongsangnam-do, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

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