Breast Cancer Clinical Trial
Official title:
A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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