An Observational Study of Herceptin SC Safety in Breast Cancer

November 13, 2020 updated by: Hoffmann-La Roche

Post-Marketing Surveillance of Herceptin Subcutaneous 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Medical Center
      • Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of, 10475
        • Myongji Hospital
      • Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Gyeongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Jeonlabuk-do, Korea, Republic of, 54538
        • Wonkwang University School of Medicine & Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 07061
        • Borame Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 01757
        • Inje University, Sanggye-Paik Hospital
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 04619
        • Cheil General Hospital & Women's Healthcare Center
      • Seoul, Korea, Republic of, (0)6351
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Miz Medi Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving treatment for breast cancer with Herceptin SC under observation according to standard of care and in line with the current local labeling in Korea.

Description

Inclusion Criteria:

- All patients administered Herceptin SC for the locally approved indications

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort
Method of continuous surveillance per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Up to 6 years
Up to 6 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2015

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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