Spots Global Cancer Trial Database for Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

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Trial Identification

Brief Title: Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Official Title: A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Study ID: NCT00146601

Conditions

Breast Cancer

Interventions

Fulvestrant

Study Description

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

Detailed Description: 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.