An Observational Study of Herceptin SC Safety in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosin University Gospel Hospital, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients administered Herceptin SC for the locally approved indications

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

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

Time frame: Up to 6 years

Secondary outcomes

Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)

Time frame: Up to 6 years
Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Dec 2, 2014
Registry last updated: Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed