Clinical Trials

JBCRG-C01

Observational study to evaluate the usefulness of trastuzumab as adjuvant therapy in patients with HER2 positive primary breast cancer: Cohort I

Status
Study Closed

Objectives
To evaluate the efficacy and safety of trastuzumab used as adjuvant therapy for operable breast cancer (Early Breast Cancer: EBC) in clinical settings in Japan

Subjects

Endpoints
Primary endpoint: Disease Free Survival, Secondary endpoint: Overall Survival, Safety

Trial Period
July 2009 - June 2014

Lead Principal Investigator
Hiroyasu Yamashiro(Dept of Breast surgery, Kyoto University Hospital)

Target Sample Size
1500

Regimen

Source of Funding
JBCRG

Conference Presentation
Safety of trastuzumab in HER2 positive primary breast cancer in Japan; Initial safety report for the large scale cohort study (JBCRG-C01) Cohort study evaluating trastuzumab in HER2 positive early breast cancer in Japan; JBCRG-C01

Articles and Publications
Outcomes of Trastuzumab Therapy in HER2-Positive Early Breast Cancer Patients: Extended Follow-up of JBCRG-Cohort Study 01 Outcomes of trastuzumab therapy in HER2‑positive early breast cancer patients (JBCRG-C01)

UMIN-ID
UMIN000002737

jRCT

Memo

COI Disclosure

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