Clinical trial NCT02305628: An Observational Study of Herceptin SC Safety in Breast Cancer
Official title: Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

- All patients administered Herceptin SC for the locally approved indications

Exclusion Criteria:

N/A

Primary outcomes:
measure: 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
timeFrame: Up to 6 years
Secondary outcomes:
measure: Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)
timeFrame: Up to 6 years
measure: Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jeonlabuk-do
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Inje University, Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Miz Medi Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: