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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03941730

Run by

Mayo Clinic

People needed

8

Starts

2019-08-28

Expected to finish

2026-12-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• PRE-SCREENING CRITERIA (STEP 0): Women of age >= 18 years
• PRE-SCREENING CRITERIA (STEP 0): History of locally advanced or metastatic breast cancer that is ERalpha negative or low (< 1% nuclear staining) and HER2 negative.
• Note: HER2 negative disease per 2018 American Society of Clinical Oncology/College of American of Pathologists (ASCO/CAP) guidelines, one of the following must apply:
• 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH);
• 0 or 1+ by IHC and ISH not done;
• 2+ by IHC and ISH results are: < 6.0 HER2 signals/cell with HER2/CEP17 ratio < 2.0;
• IHC not done and not amplified by ISH.
• PRE-SCREENING CRITERIA (STEP 0): =< 3 prior chemotherapy regimens for treatment of metastatic breast cancer.
• Note: Prior use of monoclonal antibodies targeting PD1, PDL1 is allowed (if administered as monotherapy it is not counted as a chemotherapy regimen).
• PRE-SCREENING CRITERIA (STEP 0): Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• PRE-SCREENING CRITERIA (STEP 0): Willing to submit a biopsy specimen from locally recurrent or metastatic site (or primary if metastatic site not available) of breast cancer for ERbeta staining to Mayo Clinic Anatomic Pathology.
• PRE-SCREENING CRITERIA (STEP 0): No prior history of metastatic ERalpha positive breast cancer (>= 1%)
• PRE-REGISTRATION CRITERIA (STEP 1): Presence of moderate or strong nuclear ERbeta staining in > 25% of cells in specimen submitted during Pre-Screening Step.
• PRE-REGISTRATION CRITERIA (STEP 1): For patients who did not have a biopsy or lacking ERalpha, progesterone receptor (PR), and HER2 results from a locally advanced or metastatic site performed =< 12 months prior to Pre-Registration: Willing to undergo a standard of care biopsy of locally recurrent or metastatic breast cancer for ERalpha, PR, and HER2 as well as additional research cores.
• PRE-REGISTRATION CRITERIA (STEP 1): Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria that will be assessed using imaging-based evaluations.
• Note: The tumor lesion biopsied during the pre-registration period is not considered measurable disease nor a target lesion.
• PRE-REGISTRATION CRITERIA (STEP 1): If history of brain metastases must meet the following criteria:
• Patients with a history of brain metastases are eligible only if they are asymptomatic and have stable disease for >= 3 months, including < 28 days of prior to pre-registration.
• Not receiving steroids for brain metastases.
• PRE-REGISTRATION CRITERIA (STEP 1): ECOG performance status 0 or 1.
• PRE-REGISTRATION CRITERIA (STEP 1): =< 3 prior chemotherapy regimens for treatment of metastatic breast cancer.
• NOTE: Prior use of monoclonal antibodies targeting PD1, PDL1 is allowed.
• PRE-REGISTRATION CRITERIA (STEP 1): Women must be postmenopausal.
• NOTE: Postmenopausal status is verified by:
• Prior bilateral surgical oophorectomy, or

You may not qualify if…

• PRE-REGISTRATION CRITERIA: Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection.
• Symptomatic congestive heart failure.
• Unstable angina pectoris.
• Uncontrolled symptomatic cardiac arrhythmia.
• Uncontrolled hypertension (defined as blood pressure > 160/90).
• PRE-REGISTRATION CRITERIA: Deep vein thrombosis / pulmonary embolism (DVT/PE) =< 12 months prior to pre-registration.
• Note: Patients who are on anticoagulant therapy for maintenance are eligible as long as the DVT and/or PE occurred > 6 months prior to pre-registration, and there is no evidence for active thrombosis (either DVT or PE).
• PRE-REGISTRATION CRITERIA: Stroke =< 6 months prior to pre-registration.
• PRE-REGISTRATION CRITERIA: Two or more episodes of DVT and/or PE =< 5 years prior to pre-registration.
• PRE-REGISTRATION CRITERIA: Abnormal uterine bleeding =< 6 months prior to pre-registration
• PRE-REGISTRATION CRITERIA: History of coagulopathy.
• PRE-REGISTRATION CRITERIA: Other active second malignancy other than non-melanoma skin cancers within 3 years prior to pre-registration.
• NOTE: A second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for >= 3 years prior to pre-registration.
• REGISTRATION CRITERIA: None of the following therapies are allowed =< 14 days prior to registration.
• Chemotherapy.
• Immunotherapy.
• Biologic therapy.
• Hormonal therapy.
• Monoclonal antibodies.
• Anti-HER2 or other "targeted" (e.g. mTOR) therapy.
• Note: Any adverse events derived from these therapies must be =< grade 2 prior to starting study therapy (exceptions for alopecia).

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• FHCC South Lake Union — Seattle, Washington, United States
• University of Washington Medical Center - Montlake — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.