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Hormone Therapy

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
18 years of age or older
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am female.
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My breast cancer is spreading and cannot be cured with surgery or radiation.
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I can take care of myself and am up and about more than half of my waking hours.
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I am postmenopausal according to the study's criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Secondary outcome measures
Assessment of adverse events
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698
12%
Arthralgia
11%
Fatigue
9%
Nausea
8%
Hot flush
6%
Diarrhoea
6%
Constipation
5%
Urinary tract infection
5%
Dyspnoea
5%
Vomiting
4%
Cough
4%
Back pain
3%
Musculoskeletal pain
1%
Renal Failure
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Cardiac Failure
1%
Femur Fracture
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
~3700

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,626 Total Patients Enrolled
47 Trials studying Breast Cancer
7,225 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,074 Previous Clinical Trials
340,264 Total Patients Enrolled
140 Trials studying Breast Cancer
22,531 Patients Enrolled for Breast Cancer
Brigham and Women's HospitalOTHER
1,599 Previous Clinical Trials
11,462,485 Total Patients Enrolled
46 Trials studying Breast Cancer
109,699 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary indication for Fulvestrant?

"Fulvestrant is a medication used to treat endocrine therapy, as well as other diseases such as the breast and pik3ca gene mutation."

Answered by AI

Has the government organization in charge of approving drugs given Fulvestrant its stamp of approval?

"Fulvestrant was given a safety rating of 2. Although there is some data indicating that it may be safe, there is no evidence to support its efficacy."

Answered by AI

Are there any limits to how many people can join this clinical trial?

"This study is no longer enrolling patients. It was originally posted on 4/1/2004 but has not been updated in nearly 2 years. However, there are 2699 other trials for breast cancer and 140 involving fulvestrant that are still looking for participants."

Answered by AI

Are there other drugs that have been studied in Fulvestrant clinical trials?

"Fulvestrant is being studied in 140 different active clinical trials, 33 of which are classified as Phase 3. Most of these studies originate from Shanghai, but there are 5843 total locations conducting research on Fulvestrant."

Answered by AI

Are patients still being enrolled in this trial?

"According to the information available on clinicaltrials.gov, this study has stopped recruiting patients. The trial was first advertised on April 1st 2004 and was updated for the last time on June 16th 2022. Although this particular study is not looking for participants, there are 2839 other trials that are."

Answered by AI
~2 spots leftby Mar 2025