Study on the Effectiveness and Safety of 500mg Fulvestrant for Breast Cancer
Sponsor: Beth Israel Deaconess Medical Center
ClinicalTrials ID:NCT00585507
This clinical trial is testing a higher dose of Fulvestrant to see if it can improve treatment outcomes for women with hormone receptor-positive metastatic breast cancer. The study will evaluate the safety and effectiveness of this increased dosage.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Fulvestrant is a medication used to treat hormone receptor-positive metastatic breast cancer. Previous studies have shown it to be effective, but the dose used may not be optimal. This study aims to test a higher dose to see if it leads to better results for patients.
Description
In this study, participants will receive Fulvestrant through an injection into the muscle on day 1, day 15, and day 29, and then every 28 days after that. Each time they receive treatment, they will also have a physical exam and blood tests. After finishing the study treatment, participants will have physical exams every three months for the first two years, every six months for years two to five, and once a year after five years. Participants can continue the study treatment until their disease progresses or they experience serious side effects.
Eligibility Criteria
Inclusion Criteria
- Female participants
- 18 years or older
- Diagnosed with breast cancer that has spread and cannot be cured
- Cancer shows hormone sensitivity
- Postmenopausal as defined by the study
- May have had previous hormone therapy if stopped at least 12 months before joining the study
- Previous treatment with trastuzumab and other biologics is allowed if stopped more than two weeks before joining
- Must have measurable or evaluable disease
- Must be in good overall health with a performance status score of 0, 1, or 2
Exclusion Criteria
- Have life-threatening metastatic disease
- Have received hormone therapy for advanced disease
- Have had chemotherapy within the last four weeks
- Have had trastuzumab or biologic therapy within the last two weeks
- Have had extensive radiation therapy within the last two weeks
- Have previously been treated with Fulvestrant
- Are receiving other cancer treatments
- Are on long-term anticoagulant therapy with warfarin
- Have used estrogen replacement therapy within six months of joining
- Have had another cancer within the past three years
- Have taken non-approved or investigational drugs within two weeks before joining
- Have severe or uncontrolled systemic disease
- Have a history of bleeding disorders
- Have any severe condition that makes participation undesirable or would affect compliance with the study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hosptial | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Lowell General Hospital | 01854 | Lowell | Massachusetts |
| South Shore Hospital | 02190 | South Weymouth | Massachusetts |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.