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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Massachusetts General Hospital | OTHER |
| Lowell General Hospital | OTHER |
| Brigham and Women's Hospital |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, time-to-progression, and duration of response for this patient population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig A. Bunnell, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| OTHER |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |