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

Duration: Until disease progression or serious side effects

40 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Steven Come, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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

My cancer responds to hormone therapy.

I am female.

My breast cancer is spreading and cannot be cured with surgery or radiation.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fulvestrant is administered by intramuscular injection on day 1, day 15, and day 29, then every 28 days thereafter

Until disease progression or serious side effects

In-person visits on each treatment date

Follow-up

Participants are monitored for safety and effectiveness after treatment

First 2 years: every 3 months; Years 2-5: every 6 months; Annually after 5 years

In-person visits as per schedule

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+