Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Lowell General Hospital; Massachusetts General Hospital
• Treatments: Estradiol; Fulvestrant; Hormones

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.

• Tumors must be positive for estrogen receptors, progesterone receptors, or both.

• Patients must be premenopausal.

• Prior anti-estrogen therapy (with or without ovarian suppression)

• Platelet count > 100,000/mm3

• Age older than 18 years

• ECOG performance status 0-2

Exclusion Criteria:

• Hormonal treatment for metastatic disease

• Pregnant or breast-feeding women

• Postmenopausal

• Concurrent hormonal therapy or chemotherapy

• Prior fulvestrant therapy

• More than three prior chemotherapy regimens for metastatic disease

• Concurrent, long-term anticoagulation therapy

• Severe, uncontrolled intercurrent illness

• History of hypersensitivity to castor oil