NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	HER2-overexpressing metastatic breast cancer
Date of first enrollment	01/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Trastuzumab (Herceptin) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous

Outcome(s)

Primary Outcome	1) Time to progression (TTP) on Herceptin alone (Cohort A) versus combination of Herceptin and Taxotere (Cohort B) 2) Overall survival(OS)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Female
Include criteria	Female patients and over 20 years with metastatic breast cancer, who do not have any chemotherapeutics to metastatic breast cancer. Whenever possible, the disease will be assessed for HER2 status. Patients who have HER2 overexpression or amplification in their disease(3+by immunohistochemistry or FISH positive),will be allowed to enter this study.
Exclude criteria