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Hormone Therapy
Therapeutic Estradiol for Breast Cancer
Phase 2
Waitlist Available
Led By Matthew P. Goetz, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women must be postmenopausal
Presence of moderate or strong nuclear ERbeta staining in > 25% of cells in specimen submitted during Pre-Screening Step
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well estradiol works in treating patients with a certain type of breast cancer that has spread.
Who is the study for?
This trial is for postmenopausal women with a specific breast cancer type that's spread within the body or to nearby areas. Participants must have ER beta positive, triple negative tumors and be in good general health (ECOG status 0 or 1). They should not have had more than three prior chemo treatments for metastatic breast cancer and must agree to undergo necessary biopsies.Check my eligibility
What is being tested?
The study tests how effective estradiol, a form of estrogen, is on patients whose tumor cells overexpress ER beta but lack other hormone receptors. The goal is to see if estradiol can shrink these specific types of tumor cells. Various imaging techniques like CT scans will monitor the results.See study design
What are the potential side effects?
Potential side effects from therapeutic estradiol may include an increased risk of blood clots, changes in mood or sex drive, nausea, headaches, high blood pressure, and vaginal irritation or discharge. Each person might experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have gone through menopause.
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My cancer cells show a certain level of ERbeta protein.
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I agree to provide a biopsy sample for testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor is negative for both ER and HER2.
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I have had 3 or fewer chemotherapy treatments for my metastatic breast cancer.
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I can take pills by mouth.
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My breast cancer is not driven by estrogen or HER2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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
Changes in phospho-ERbeta, cystatins 1, 2, 4 and 5, phospho-Smad2/3 and Ki-67
Incidence of adverse events
Overall survival distribution
+2 moreOther outcome measures
Changes in serum cystatin levels in response to treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (estradiol)Experimental Treatment5 Interventions
Patients receive estradiol PO TID for days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tissue biopsy at the end of cycle 1, collection of blood samples on C1D1, at the end of cycle 1, and at the end of treatment. In addition, patients undergo CT, MRI, or PET scans at baseline, at the end of cycles 2, 4, and 6, and then every 8 weeks until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,826 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,285 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Matthew P. Goetz, M.D.Principal InvestigatorMayo Clinic
3 Previous Clinical Trials
392 Total Patients Enrolled
2 Trials studying Breast Cancer
192 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clotting disorders.I have had 2 or more blood clots in the last 5 years.My cancer's size or presence can be tracked with scans.Your hemoglobin level should be at least 8 grams per deciliter within 14 days before joining the study.I have gone through menopause.I am willing to have a biopsy for breast cancer markers if I haven't had one in the last year.My cancer cells show a certain level of ERbeta protein.I agree to provide a biopsy sample for testing.I have not had a blood clot in my veins or lungs in the last year.I do not have any serious ongoing illnesses, including heart problems or uncontrolled high blood pressure.I am willing to stop taking certain medications that affect how my body processes drugs.Your creatinine levels are within a certain range, as tested within the last 14 days before joining the study.I am a woman aged 18 or older.I haven't had chemotherapy, immunotherapy, or other specific cancer treatments in the last 14 days.My brain metastases meet specific health criteria.Your total bilirubin level must be no more than 1.5 times the upper limit of normal within 14 days before enrolling in the study.My liver function tests are within the required range.I am fully active or restricted in physically strenuous activity but can do light work.I have not had a stroke in the last 6 months.My tumor is negative for both ER and HER2.I have had 3 or fewer chemotherapy treatments for my metastatic breast cancer.Your platelet count should be at least 75,000 per cubic millimeter within 14 days before joining the study.I have had abnormal bleeding from my uterus in the last 6 months.I have not had any cancer other than non-melanoma skin cancer in the last 3 years.I can take pills by mouth.My breast cancer is not driven by estrogen or HER2.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (estradiol)
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.
Are there long-term risks associated with taking Therapeutic Estradiol?
"Power's team has rated the safety of Therapeutic Estradiol as a 2. This is due to it being in Phase 2 clinical trials, where there is evidence of safety but not yet efficacy."
Answered by AI
Are participants being recruited for this clinical research at present?
"That is correct.if you visit clinicaltrials.gov, you'll see that the most recent update to this study was on 8/31/2022. The trial is seeking 38 individuals who are willing to participate at 14 different locations."
Answered by AI
In how many different geographical areas is this trial taking place?
"Presently, this trial is being conducted in 14 different centres. These locations include Jacksonville, Chicago and Bronx as well other surrounding areas. If you are interested in enrolling, it would be beneficial to choose the site closest to your residence to cut down on commute times."
Answered by AI
How many people are helping to test this new medication?
"Yes, the data on clinicaltrials.gov indicates that this study is looking for participants. The trial was first posted on 8/28/2019 and was last updated on 8/31/2022. 38 patients need to be recruited from 14 different sites."
Answered by AI
Do you know of any other times when Therapeutic Estradiol has been studied?
"Estradiol's therapeutic effects were first investigated in 1996 at the National Institutes of Health Clinical Center. To date, there have been a total of 351 completed trials worldwide. There are currently 52 live clinical trials, with a significant portion taking place in Jacksonville, Florida."
Answered by AI
What are the benefits of taking Therapeutic Estradiol?
"Therapeutic Estradiol is most commonly used to treat amenorrhea, or the absence of a menstrual period, in women who have not had one in the last 6 months. However, it can also be helpful for managing other conditions like hypoestrogenism, menopausal vasomotor symptoms, and breast cancer."
Answered by AI
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