Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.

Routine blood tests will be performed each time an injection is given.

Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.

After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.

Patients will continue to receive treatment as long as there is no disease progression or serious side effects.

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