An Observational Study of Herceptin SC Safety in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-26

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Method of continuous surveillance per standard of care

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

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South Korea

Other Identifiers

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ML29625

Identifier Type: -

Identifier Source: org_study_id

An Observational Study of Herceptin SC Safety in Breast Cancer

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Cohort

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hoffmann-La Roche

Responsible Party

Principal Investigators

Clinical Trials

Locations

Pusan National University Hospital

Kosin University Gospel Hospital

Keimyung University Dongsan Medical Center

Myongji Hospital

Hallym University Sacred Heart Hospital

Ajou University Medical Center

Pusan National University Yangsan Hospital

Gyeongsang National University Hospital

Gachon University Gil Medical Center

Inha University Hospital

Chonnam National University Hwasun Hospital

Wonkwang University School of Medicine & Hospital

Samsung Medical Center

Inje University, Sanggye-Paik Hospital

Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences

Severance Hospital, Yonsei University Health System

Cheil General Hospital & Women's Healthcare Center

Gangnam Severance Hospital

ChungAng University Hospital

Borame Medical Center

Ewha Womans University Mokdong Hospital

Miz Medi Hospital

Ulsan University Hosiptal

Countries

Other Identifiers

ML29625