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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%
Diarrhea
17%
Headache
17%
Mucositis
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Pruritus
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
5%
Pain
5%
Dysgeusia
3%
Nail disorder
3%
Respiratory infection
3%
Abdominal pain
1%
Osteonecrosis of jaw
1%
Spinal cord compression
1%
Heart failure
1%
Bronchial infection
1%
Pleural effusion
1%
Ascites
1%
Urinary tract infection
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Renal failure
1%
Dislocation of hip
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Thromboembolic event
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
~3510

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,840,195 Total Patients Enrolled
45 Trials studying Breast Cancer
107,967 Patients Enrolled for Breast Cancer
Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,921 Total Patients Enrolled
47 Trials studying Breast Cancer
4,551 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,197 Total Patients Enrolled
144 Trials studying Breast Cancer
20,172 Patients Enrolled for Breast Cancer
~0 spots leftby Mar 2025
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