Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00146601

Run by

Dana-Farber Cancer Institute

People needed

35

Starts

2004-06-01

Expected to finish

2007-07-01

Last updated by the study team

2007-12-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lowell General Hospital — Lowell, Massachusetts, United States

Full record on ClinicalTrials.gov

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