NCT02305628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

June 26, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4.6 years

First QC Date

November 28, 2014

Last Update Submit

November 13, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Cohort

Method of continuous surveillance per standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Myongji Hospital

Gyeonggi-do, 10475, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

Location

Pusan National University Yangsan Hospital

Gyeongsangnam-do, 50612, South Korea

Location

Gyeongsang National University Hospital

Gyeongsangnam-do, 52727, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Wonkwang University School of Medicine & Hospital

Jeonlabuk-do, 54538, South Korea

Location

Samsung Medical Center

Seoul, (0)6351, South Korea

Location

Inje University, Sanggye-Paik Hospital

Seoul, 01757, South Korea

Location

Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences

Seoul, 01812, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Cheil General Hospital & Women's Healthcare Center

Seoul, 04619, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

ChungAng University Hospital

Seoul, 06973, South Korea

Location

Borame Medical Center

Seoul, 07061, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Miz Medi Hospital

Seoul, South Korea

Location

Ulsan University Hosiptal

Ulsan, 44033, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 2, 2014

Study Start

June 26, 2015

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

KR(23)