Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

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

• 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

• Oestrogen-receptor positive tumour

• Written informed consent to participate in the trial

Exclusion Criteria:

• Treatment with an investigational or non-approved drug within one month

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

• A history of allergies to any active or inactive ingredients of fulvestrant (i.e. castor oil)

• Treatment with more than one regimen of chemotherapy for advanced breast cancer

• Treatment with more than one regimen of hormonal treatment for advanced breast cancer