Study on Estradiol for Treating ER Beta Positive, Triple Negative Advanced or Metastatic Breast Cancer
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT03941730
This clinical trial is exploring how well the hormone estradiol works in treating patients with a specific type of breast cancer known as ER beta positive, triple negative breast cancer, which has spread locally or to other parts of the body.
Patient Parameters
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Program Overview
This study is investigating whether estradiol, a form of estrogen, can help shrink tumors in patients with a type of breast cancer called ER beta positive, triple negative breast cancer. This cancer does not have certain hormone receptors but does have the ER beta receptor, which may slow tumor growth when exposed to estrogen. The trial aims to see if estradiol can effectively reduce tumor size in these patients.
Description
The main goal of this study is to see if estradiol can reduce tumor size in patients with advanced or metastatic triple negative breast cancer that has the ER beta receptor. Patients will take estradiol pills three times a day for 28 days, with cycles repeating every 28 days as long as the cancer does not worsen and side effects are manageable.
Secondary goals include checking the safety of estradiol at the given dose and examining changes in certain proteins and genes in tumor samples before and after treatment. Blood samples will also be collected to study changes in hormone and protein levels.
Patients will undergo scans like CT, MRI, or PET at the start, after cycles 2, 4, and 6, and then every 8 weeks to monitor the cancer. After finishing the treatment, patients will have yearly follow-ups for five years.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Have a history of advanced or metastatic breast cancer that is ER alpha negative and HER2 negative.
- Have received no more than three prior chemotherapy treatments for metastatic breast cancer.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Willing to provide a tumor sample for testing.
- No history of ER alpha positive metastatic breast cancer.
- Have moderate or strong ER beta staining in more than 25% of tumor cells.
- Postmenopausal women, verified by age, surgical history, or hormone levels.
- Able to swallow pills and willing to stop certain medications before starting the study.
- Meet specific blood test requirements for hemoglobin, platelets, creatinine, bilirubin, and liver enzymes.
Exclusion Criteria
- Have uncontrolled illnesses like infections, heart failure, or high blood pressure.
- Have had blood clots or strokes recently.
- Have abnormal uterine bleeding or a history of blood clotting disorders.
- Have another active cancer within the last three years, except for certain skin cancers.
- Have received chemotherapy, immunotherapy, or other cancer treatments within 14 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| UCSF Medical Center-Mission Bay | 94158 | San Francisco | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Montefiore Medical Center-Einstein Campus | 10461 | The Bronx | New York |
| FHCC South Lake Union | 98109 | Seattle | Washington |
| University of Washington Medical Center - Montlake | 98195 | Seattle | Washington |
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