An Observational Study of Herceptin SC Safety in Breast Cancer

Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02305628

Enrollment

600

Registered

2014-12-02

Start date

2015-06-26

Completion date

2020-01-31

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- All patients administered Herceptin SC for the locally approved indications

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)	Up to 6 years
Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)	Up to 6 years

Countries

South Korea

Outcome results