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NCT03941730 · ClinicalTrials.gov registry record · Phase 2
Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 9
- Study locations
NCT03941730: Active Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
NCT03941730 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 8 participants, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03941730, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase II trial studies how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Hormone receptors like ER beta allow the body to respond appropriately to hormones. Triple negative means that the breast cancer does not express other hormone receptors called ER alpha, progesterone, and HER2. In some people with triple negative breast cancer, ER beta is overexpressed. Tumor cells that overexpress ER beta grow slower in the laboratory and this growth is slowed in the presence of estrogen. Estradiol is a form of estrogen. This study may help doctors determine whether tumor cells that overexpress ER beta shrink in the presence of estradiol.
Primary Outcome
A patient is said to have derived clinical benefit rate at the 6 month time point if the patient's disease meets the Response Evaluation Criteria in Solid Tumors (RECIST) for complete response (CR), partial response (PR), or stable disease (SD) for \> 6 months following initiation of treatment. The 6 month clinical benefit rate is the percentage of patients who are found to meet the criteria for clinical benefit at least 6 months among all the patients who have started estradiol treatment. As th
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- BIOLOGICAL Therapeutic Estradiol
Study Locations (9)
Washington
- FHCC South Lake Union - Seattle
- University of Washington Medical Center - Montlake - Seattle
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- UCSF Medical Center-Mission Bay - San Francisco
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Mayo Clinic in Florida - Jacksonville
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Minnesota
- Mayo Clinic in Rochester - Rochester
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03941730 still lists
NCT03941730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03941730 lists 9 locations in 8 states (Washington, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT03941730 about?
NCT03941730 is a clinical study titled "Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer". This phase II trial studies how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Hormone receptors like ER beta allow th...
What is the current status of trial NCT03941730?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2019-08-28. Estimated completion is 2026-12-31.
What conditions does trial NCT03941730 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Recurrent Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Advanced Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT03941730?
The interventions under investigation include: Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Therapeutic Estradiol (BIOLOGICAL).
Who is sponsoring clinical trial NCT03941730?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03941730 being conducted?
This trial has 9 study locations across Alabama, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03941730's enrollment target sits among peer trials
8 85th of 84 the lowest of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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