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

UMIN ID: UMIN000001217

Registered date:29/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Premenopausal breast cancer
• Date of first enrollment: 2008/09/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Goserelin acetate 3.6mg depot/ q 4w + Anastrozole 1mg/d

Outcome(s)

• Primary Outcome: Clinical response rate
• Secondary Outcome: 1.Progression free survival 2.Overall survival 3.Clinical benefit rate 4.Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 55years-old
• Gender: Female
• Exclude criteria: Patients 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

• Primary Sponsor: The Japan-Multinational Trial Organization
• Source(s) of Monetary Support: The Japan-Multinational Trial Organization