Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Estradiol; Estrogens; 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

• Evidence of positive estrogen receptor hormone sensitivity

• 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 Faslodex (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