NIPH Clinical Trials Search

UMIN ID: UMIN000001217

Registered date:29/06/2008

Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxifen

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPremenopausal breast cancer
Date of first enrollment2008/09/01
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Goserelin acetate 3.6mg depot/ q 4w + Anastrozole 1mg/d


Primary OutcomeClinical response rate
Secondary Outcome1.Progression free survival 2.Overall survival 3.Clinical benefit rate 4.Adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum55years-old
Include criteria
Exclude criteriaPatients falling under any of the following 1.Patients with a history of drug allergy against the test drug and co-administered drug 2.Patients administered another anticancer drug since the prior treatment [LH-RHa + TAM therapy or LH-RHa + TAM followed by TAM therapy] 3.Patients receiving ongoing systemic administration [orally or intravenously] of an adrenal cortex hormone 4.Patients with advanced cancer in another organ less than 5 years after the completion of treatment 5.Patients with a history of thrombotic disease such as deep vein thrombosis or cerebral infarction 6.Patients with a history of severe heart disease such as myocardial infarction, valvular heart disease or heart failure 7.Patients receiving administration of HRT for treatment of menopausal symptoms within 4 weeks of registration 8.Women who are pregnant, lactating or may be [intend to be] pregnant 9.Patients planning treatment with an anticancer drug other than LH-RHa + Anastrozole, a bisphosphonate or radiation therapy on a target lesion following the start of this trial 10.Other cases who the doctor responsible for the trial judges unsuitable

Related Information


public contact
Address Japan
Telephone 075-241-4894
Affiliation The Japan-Multinational Trial Organization Operating Office
scientific contact
Name Reiki Nishimura
Address 1-1-60 Kotoh, Kumamoto City, Kumamoto Japan
Affiliation Kumamoto City Hospital Breast & Endocrine Surgery