Could estrogen shrink some triple negative breast tumors?
NCT ID NCT03941730
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 Hide 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced triple-negative breast carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug cocktail make immunotherapy work better for Hard-to-Treat breast cancer?
- Can a Tumor-Blood-Vessel blocker boost hormone therapy for advanced breast cancer?
- Can a Weight-Loss drug shield breast cancer Survivors' hearts?
- Fasting during chemo: a new way to boost treatment?
- Gut bacteria may fortify bones in breast cancer therapy
- Can a smart drug cross the Blood-Brain barrier to attack breast cancer metastases?