Higher Dose Fulvestrant for Breast Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticancer, Anticoagulants, Estrogen, others

Disqualifiers: Life-threatening metastasis, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.

Research Team

Steven Come, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for postmenopausal women with hormone-sensitive breast cancer that has spread and can't be cured by surgery or radiation. They should have a good performance status, meaning they're fairly active and self-sufficient. Women who've had certain previous treatments are eligible if enough time has passed since those treatments.

Inclusion Criteria

I am 18 years old or older.

My cancer responds to hormone therapy.

I am female.

Exclusion Criteria

I am not receiving any other cancer treatments.

I have not had Trastuzumab or similar treatments in the last 2 weeks.

I have not had extensive radiation therapy in the last 2 weeks.

Treatment Details

Interventions

• Fulvestrant

Trial Overview The study is testing whether a higher dose of Fulvestrant (500mg) will be more effective in treating metastatic breast cancer than the doses used before. The drug targets hormone receptors to slow down or stop cancer growth.

Participant Groups

Group I: single Experimental Treatment 1 Intervention

fulvestrant 500mg

Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in United States as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Canada as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Japan as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Lowell General Hospital

Collaborator

Trials

11

Recruited

7,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Maryland Greenebaum Cancer Center

Collaborator

Trials

15

Recruited

430+

South Shore Hospital

Collaborator

Trials

13

Recruited

10,800+