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New drug shows promise in slowing advanced breast cancer with ESR1 mutation

NCT ID NCT03781063

Disease control Sponsor: Sermonix Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug, lasofoxifene, against the standard treatment fulvestrant in 100 women with advanced ER+/HER2- breast cancer that has a specific mutation in the ESR1 gene. The goal was to see if lasofoxifene could delay cancer growth better than fulvestrant. Participants had already tried other treatments without success. The study measured how long the cancer stayed under control and tracked side effects and quality of life.

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

100 people

The number who actually took part.

Started

Sep 2019

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Pre- or postmenopausal. Postmenopausal women are defined as: 1. ≥60 years of age with no vaginal bleeding over the prior year, or 2. \<60 years with "premature menopause" or "premature ovarian failure" manifest itself with secondary amenorrhea for at least 1 year and follicle stimulating hormone (FSH) and estradiol levels in the postmenopausal range according to institutional standards, or 3. surgical menopause with bilateral oophorectomy. Note: premenopausal women who meet all of the other entry criteria must be maintained on ovarian suppression (such as Lupron) during the study and subjects counseled to use appropriate contraception to prevent pregnancy. 2. If possible, a biopsy of metastatic breast cancer tissue will be obtained to provide histological or cytological confirmation of ER+ and HER2- disease as assessed by a local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is not possible, the ER and HER2 status from the tissue obtained at the time of the original diagnosis must confirm that the subject's cancer is ER+ and HER2-. 3. Locally advanced or metastatic breast cancer with radiological or clinical evidence of progression on an AI in combination with a CDK 4/6 inhibitor for advanced breast cancer with demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in the metastatic setting). 4. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions. 5. At least one or more of the following point ESR1 mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood (plasma) or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. The ctDNA sample collection must be obtained within 30 days prior to randomization to determine eligibility and baseline. Note: a prior genomic test confirming that the subject has an ESR1 mutation can be used to determine eligibility; however, an ESR1 sample must also be collected within 30 days of randomization. 6. Subjects who have not received cytotoxic chemotherapy or those who have received one cytotoxic chemotherapy regimen in the neo-adjuvant or adjuvant setting prior to entry into the trial and/or no more than one chemotherapy regimen for metastatic breast cancer. Subjects must be free of all chemotherapy acute toxicity excluding alopecia and Grade II peripheral neuropathy before study entry. 7. ECOG performance score of 0 or 1. 8. Adequate organ function as shown by: 1. absolute neutrophil count (ANC) \>/=1,500 cells/mm3 2. platelet count ≤100,000 cells/mm3 3. hemoglobin \>/=9.0 g/dl 4. ALT and AST levels ≤2.5 upper limit of normal (ULN) or ≤5 in the presence of visceral metastasis 5. total serum bilirubin ≤1.5 X ULN (≤ 3 X ULN for subjects known to have Gilbert Syndrome) 6. alkaline phosphatase level ≤ 2.5 X ULN 7. creatinine clearance of 40 ml/min or greater as calculated by the Cockcroft-Gault formula 8. International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) \<2.0 X ULN. 9. Able to swallow tablets. 10. Able to understand and voluntarily sign a written informed consent before any screening procedures. Exclusion Criteria: 1. Prior use of everolimus or other mammalian target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinase inhibitor (PI3K) inhibitors is excluded unless discontinued to reasons other than disease progression. 2. Presence of brain metastasis. 3. Lymphangitic carcinomatosis involving the lung. 4. Impending visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator. 5. Radiotherapy within 30 days prior to randomization except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization. 6. History of long QTC syndrome or a QTC of \>480 ms. 7. History of a pulmonary embolus (PE) or deep vein thrombosis (DVT) within the last 6 months or any known thrombophilia. Subjects stable on anti-coagulants for maintenance are eligible as long as the DVT and/or PE occurred \>6 months prior to enrollment and there is no evidence for active thrombosis. The use of low dose ASA is permitted. 8. Any significant co-morbidity that would impact the study or the subject's safety. 9. History of a positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening. Subjects cured of hepatitis C (no viral load) are eligible. 10. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery, or early stage cervical cancer. 11. History of vaginal bleeding over the last year unless it is documented that the bleeding was due to non-uterine causes (e.g. vaginal atrophy). 12. Uncontrolled hypertension defined as sitting systolic pressure \>160 mm Hg or diastolic pressure \>100 mm Hg at Screening. 13. History of non-compliance to medical regimens. 14. Unwilling or unable to comply with the protocol. 15. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

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

Locally advanced or metastatic breast cancer

Contacts and locations

Locations

  • Beacon Health (JIT)

    South Bend, Indiana, 46601, United States

  • CIUSSS de Saguenay-Lac-Saint Jean

    Chicoutimi, Quebec, G7H5H6, Canada

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • City of Hope Comprehensive Cancer

    Duarte, California, 91010, United States

  • Compassionate Care Research Group

    Fountain Valley, California, 92708, United States

  • Comprehensive Cancer Centers of Nevada (JIT)

    Las Vegas, Nevada, 89128, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • FMH James M Stockman Cancer Institute (JIT)

    Frederick, Maryland, 21702, United States

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308, United States

  • HCA Midwest Health

    Kansas City, Missouri, 64132, United States

  • Hadassah Ein Kerem Medical Center

    Jerusalem, Israel, 9112001, Israel

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Hawaii Cancer Care (JIT)

    Honolulu, Hawaii, 96813, United States

  • Illinois Cancer Care (JIT)

    Peoria, Illinois, 61615, United States

  • Jewish General Hospital

    Montreal, Quebec, H3T1E2, Canada

  • Mary Crowley Cancer Research (JIT)

    Dallas, Texas, 75230, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1, Canada

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • New Jersey Cancer Care and Blood Disorders (JIT)

    Belleville, New Jersey, 07203, United States

  • Ocala Oncology Center (JIT)

    Oscala, Florida, 34474, United States

  • Ohio Health (JIT)

    Columbus, Ohio, 43221, United States

  • Oncology Consultants (JIT)

    Houston, Texas, 77024, United States

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601, United States

  • Rabin Medical Center

    Petah Tikva, Israel, 49100, Israel

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611, United States

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Sanford Cancer Center (JIT)

    Sioux Falls, South Dakota, 57104, United States

  • Sheba Medical Center

    Ramat Gan, Israel, 52656021, Israel

  • Soroka University Medical Center

    Beersheba, Israel, 84101, Israel

  • Summit Medical Group (JIT)

    Florham Park, New Jersey, 07932, United States

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N3M5, Canada

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology/SCRI

    Nashville, Tennessee, 37203, United States

  • The Bond Clinic Cancer & Research Center.

    Winter Haven, Florida, 33880, United States

  • The Ohio State University - Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6, Canada

  • TriHealth Cancer Institute

    Cincinnati, Ohio, 45220, United States

  • UCSF Cancer Center

    San Francisco, California, 94115, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Louisville / James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • Utah Cancer Specialists (JIT)

    Salt Lake City, Utah, 84102, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Cancer Center

    Germantown, Tennessee, 38138, United States

  • Yuma Regional Medical Center (JIT)

    Yuma, Arizona, 85364, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.