Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Fulvestrant

Study type

Interventional

Funder types

Other

Identifiers

NCT00146601
04-075

Details and patient eligibility

About

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

Full 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.

Enrollment

35 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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