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Hormone Therapy

Higher Dose Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Led By Steven Come, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test whether a higher dose of fulvestrant, a medication used to treat hormone receptor positive breast cancer, is more effective than the standard dose. The higher dose is expected to be well tolerated.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Fulvestrant may cause side effects such as nausea, injection site pain, weakness, headache, hot flashes, and back pain. Since this trial uses a higher dose than usual, there might be an increased risk of these or other side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698
12%
Arthralgia
11%
Fatigue
9%
Nausea
8%
Hot flush
6%
Constipation
6%
Diarrhoea
5%
Urinary tract infection
5%
Dyspnoea
5%
Vomiting
4%
Cough
4%
Back pain
3%
Musculoskeletal pain
1%
Renal Failure
1%
Femur Fracture
1%
Pulmonary Embolism
1%
Cardiac Failure
1%
Pleural Effusion
1%
Pneumonia
1%
Sepsis
1%
Back Pain
1%
Dizziness
1%
Syncope
1%
Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fulvestrant + Anastrozole
Anastrozole

Trial Design

1Treatment groups
Experimental Treatment
Group I: singleExperimental Treatment1 Intervention
fulvestrant 500mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,653 Previous Clinical Trials
11,490,995 Total Patients Enrolled
46 Trials studying Breast Cancer
109,692 Patients Enrolled for Breast Cancer
Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,930,064 Total Patients Enrolled
48 Trials studying Breast Cancer
6,416 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,100 Previous Clinical Trials
353,057 Total Patients Enrolled
144 Trials studying Breast Cancer
21,972 Patients Enrolled for Breast Cancer
~1 spots leftby Mar 2025
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