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Hormone Therapy
Estradiol for Advanced Breast Cancer (ESTHER Trial)
Phase 2
Recruiting
Led By Gary Schwartz, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or locoregional recurrence not amenable to treatment with curative intent
Post-menopausal women with ER+ breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ESTHER Trial Summary
This trial looks at whether women with mutated or amplified ESR1 breast cancer may benefit more from hormone therapy than those with normal ESR1.
Who is the study for?
This trial is for post-menopausal women with ER+ advanced breast cancer who have tried at least one endocrine therapy before. It's not suitable for those with a recent heart attack, congestive heart failure, high-risk previous cancers, stroke history, brain metastases unless stable for 3 months, or a history of blood clots.Check my eligibility
What is being tested?
The ESTHER study is testing if estradiol treatment benefits patients whose breast cancer has specific ESR1 mutations more than those without these mutations. No other anti-cancer treatments are allowed during the trial except certain bone therapies and Trastuzumab in some cases.See study design
What are the potential side effects?
Potential side effects of estradiol may include but are not limited to increased risk of blood clots, changes in mood or libido, nausea, headaches, and possible aggravation of existing health conditions related to the heart or circulation.
ESTHER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread or returned and cannot be cured with treatment.
Select...
I am a post-menopausal woman with estrogen receptor-positive breast cancer.
Select...
I have had hormone therapy for advanced cancer.
ESTHER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate
Secondary outcome measures
Adverse event profiles
Objective response rate
Progression-free survival
+1 moreSide effects data
From 2018 Phase 4 trial • 64 Patients • NCT0225517518%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed
ESTHER Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
2008
Completed Phase 4
~3960
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,540,753 Total Patients Enrolled
29 Trials studying Breast Cancer
2,352,830 Patients Enrolled for Breast Cancer
Gary Schwartz, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
9 Previous Clinical Trials
450 Total Patients Enrolled
2 Trials studying Breast Cancer
17 Patients Enrolled for Breast Cancer
Mary Chamberlin, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
5 Previous Clinical Trials
192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on cancer treatments except possibly Trastuzumab or bone therapies.My brain condition has been stable for at least 3 months.I have had a heart attack before.My cancer has spread or returned and cannot be cured with treatment.I am a post-menopausal woman with estrogen receptor-positive breast cancer.I have had a stroke in the past.I have a history of heart failure.I had cancer before that wasn't treated to cure, or it's likely to come back.I have had hormone therapy for advanced cancer.I have had deep vein thrombosis in the past.I have had a pulmonary embolism before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Estradiol a risk-free medication?
"The safety of Estradiol was rated as a 2, since Phase 2 trials provide limited evidence to support its protective qualities but none that suggest it is effective."
Answered by AI
How many individuals are being accepted into this clinical trial?
"Affirmative. Information available on clinicaltrials.gov suggests that this medical trial, which was initially posted on the 4th of May 2023, is currently enrolling participants. The study requires 36 patients from a single research facility."
Answered by AI
Are there vacancies in this clinical trial for participants?
"As indicated on clinicaltrials.gov, this research is actively searching for participants; the study being initially posted to the website in May of 2023 and recently updated in July."
Answered by AI
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