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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
No Placebo-Only Group

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 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3790

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,843,426 Total Patients Enrolled
45 Trials studying Breast Cancer
107,967 Patients Enrolled for Breast Cancer
Beth Israel Deaconess Medical CenterLead Sponsor
859 Previous Clinical Trials
12,932,456 Total Patients Enrolled
47 Trials studying Breast Cancer
4,551 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,110 Previous Clinical Trials
358,258 Total Patients Enrolled
144 Trials studying Breast Cancer
20,165 Patients Enrolled for Breast Cancer
Massachusetts General HospitalOTHER
3,023 Previous Clinical Trials
13,317,909 Total Patients Enrolled
79 Trials studying Breast Cancer
131,131 Patients Enrolled for Breast Cancer
Lowell General HospitalOTHER
10 Previous Clinical Trials
6,963 Total Patients Enrolled
3 Trials studying Breast Cancer
199 Patients Enrolled for Breast Cancer
University of Colorado, DenverOTHER
1,809 Previous Clinical Trials
2,822,218 Total Patients Enrolled
29 Trials studying Breast Cancer
6,849 Patients Enrolled for Breast Cancer
University of Maryland Greenebaum Cancer CenterOTHER
14 Previous Clinical Trials
386 Total Patients Enrolled
1 Trials studying Breast Cancer
12 Patients Enrolled for Breast Cancer
South Shore HospitalOTHER
12 Previous Clinical Trials
10,801 Total Patients Enrolled
Steven Come, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
~0 spots leftby Mar 2025
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