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Could estrogen shrink some triple negative breast tumors?

NCT ID NCT03941730

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial at Mayo Clinic tests whether estradiol, a form of estrogen, can help patients with a specific subtype of triple negative breast cancer that has a receptor called ER beta. The study enrolls 8 women with advanced or metastatic disease. Researchers will measure how many patients have their disease controlled for at least 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
estradiol (a form of estrogen)
What this could lead to
If it works, this could point toward a hormone-based treatment option for a subset of triple negative breast cancer patients whose tumors have a specific receptor (ER beta).
What could go wrong
This is a very small early-phase trial (only 8 participants) and results may not apply to all patients. Estrogen therapy can also stimulate some cancers, so safety is closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Age \>= 60 years, or * Age \< 60 years with no menses for \> 1 year with estradiol levels within postmenopausal range, according to institutional standard. * PRE-REGISTRATION CRITERIA (STEP 1): Able to swallow oral medications. * PRE-REGISTRATION CRITERIA (STEP 1): Willingness to stop use of strong inducers or inhibitors of CYP3A4 prior to registration. * NOTE: Use of strong inducers or inhibitors is allowed during pre-registration as long as patient will complete course prior to registration. * REGISTRATION CRITERIA (STEP 2): For patents who had a biopsy taken from a metastatic site =\< 12 months prior to Pre-Registration: Confirmation from the local lab that the tumor from this biopsy was ERalpha negative (\< 1% nuclear staining) and HER2 negative * REGISTRATION CRITERIA (STEP 2): For patients who underwent a pre-registration biopsy: Histologic confirmation from local lab that tumor is ERalpha negative (\< 1% nuclear staining), and HER2 negative * REGISTRATION CRITERIA (STEP 2): Hemoglobin \>= 8 g/dL (=\< 14 days prior to registration). * REGISTRATION CRITERIA (STEP 2): Platelet count \>= 75,000/mm\^3 (=\< 14 days prior to registration). * REGISTRATION CRITERIA (STEP 2): Creatinine =\< 1.5 x upper limit of normal (ULN) (=\< 14 days prior to registration). * REGISTRATION CRITERIA (STEP 2): Total bilirubin =\< 1.5 x ULN (=\< 14 days prior to registration). * REGISTRATION CRITERIA (STEP 2): Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) =\< 2.5 x ULN (=\< 14 days prior to registration). * For patients with liver metastasis =\< 5 x ULN. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • FHCC South Lake Union

    Seattle, Washington, 98109, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

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