An Observational Study of Herceptin SC Safety in Breast Cancer

Hoffmann-La Roche600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- All patients administered Herceptin SC for the locally approved indications Exclusion Criteria: N/A

Locations (23)

Pusan National University Hospital

Busan, South Korea

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.