A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

• Requiring hormonal treatment

• Postmenopausal women defined as a woman who has stopped having menstrual periods

Exclusion Criteria:

• Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer

• Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer

• An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures