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Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer

NCT03941730 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-12

Study results available
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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.

Conditions

  • Advanced Triple-Negative Breast Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma
  • Recurrent Breast Carcinoma

Interventions

PROCEDURE

Biopsy

Undergo tissue biopsy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

BIOLOGICAL

Therapeutic Estradiol

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Matthew P. Goetz, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2024-07-29
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941730 on ClinicalTrials.gov