NIPH Clinical Trials Search

Phase I/II study eribulin mesylate and lapatinib for metastatic in patients with human epidermal growth factor receptor 2-positive breast cancer previously treated with an anthracycline, taxane and trastuzumab

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Unresectable advanced or recurrent breast cancer
Date of first enrollment	2013/07/05
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Eribulin mesylate administer day 1, day 8, tri-weekly interval. Lapatinib administer continuously. The trial treatment will be continued until there is progressive disease.

Outcome(s)

Primary Outcome	Phase I:Determination of the recommended dose and maximum tolerated dose Phase II:The response rate in the recommended dose
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	75years-old
Gender	Female
Include criteria
Exclude criteria	a)Patients with brain metastases with symptoms b)Patients with the body cavity fluid marked (pleural effusion, ascites, pericardial effusion). However, it can be registered if good control due to the administration of adhesion agent. c)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy d)Patients with complications is determined causing serious problems in the implementation of treatment - Patients with poor control diabetes - Patients with activity infection - Patients with pulmonary fibrosis or interstitial pneumonia on chest X-ray - Patient with protocol difficult-to-treat caused by the mental state or neuropsychiatric disorders - Patients with watery diarrhea chronic - Patients with ileus, significant bleeding tendency, and gastrointestinal bleeding - Patients with uncontrolled angina and myocardial infarction and heart disease merger severe cases with heart failure that developed within three months e)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant