Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Dana-Farber Cancer Institute35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

FulvestrantDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant

Secondary Outcomes

To determine the safety, time-to-progression, and duration of response for this patient population

Data from ClinicalTrials.gov

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