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Breast CancerPhase 1/2NCT04791384

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

A Phase 1/2 study testing Abemaciclib and Elacestrant in people with Breast Cancer, run by Criterium, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Abemaciclib and Elacestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
4 sitesUnited States
Study dates
21 Apr 2022to 17 Sep 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be eligible for inclusion in this study if all of the following criteria apply:
  • Post-menopausal women with histologically or cytologically diagnosed metastatic HR+/Her2- breast cancer defined as positive for estrogen receptor or progesterone receptor (more than 1% staining by immunohistochemistry, as defined in 2010 ASCO recommendations, Hammond 2010) and negative for HER2 amplification (immunohistochemistry result of 0-1+, or a negative in situ hybridization).
  • Post-menopausal status is defined as:
  • Documented surgical bilateral oophorectomy
  • Age > 59 years with amenorrhea for > 1 year since last menses
  • Age < 60 years with amenorrhea for > 1 year since last menses and serum estradiol and FSH in post-menopausal laboratory range.
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  • Patients must have measurable brain metastasis (patients with leptomeningeal disease and measurable parenchymal disease are permitted) with documented intracranial disease progression. One measurable lesion >10mm, or previously irradiated lesion with increase in size by at least 5mm as defined by RANO-BM criteria and revised RECIST criteria (version 1.1, Appendix C). Patients with prior whole brain radiotherapy are permitted.
  • Prior treatment with up to two lines of systemic chemotherapy for metastatic disease and two weeks from any previous anticancer therapy including biologics and recovered from expected toxicity; at least 4 weeks from major surgery and recovered; at least 3 weeks from radiation affecting more than 25% of bone marrow and recovered; and 2 weeks from other palliative radiation and recovered.
  • ECOG performance status ≤ 2 (see Appendix B).
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 14 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy
  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
  • The patient has adequate organ function for all of the following criteria, as defined in Table 1 below.
  • Table 1: Laboratory Value Guidance to Establish Adequate Organ Function System Laboratory Value Hematologic ANC: >/= 1.5 × 109/L Platelets: >/=100 × 109/L Hemoglobin: >/=8 g/dL
  • Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
  • Hepatic Total bilirubin: </= 1.5 × ULN Patients with Gilbert's syndrome with a total bilirubin </=2.0 times ULN and direct bilirubin within normal limits are permitted.
  • ALT and AST: </= 3 × ULN
  • Renal Serum creatinine: </= 1.5 × ULN Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; ULN = upper limit of normal.
  • Ability to take oral medications.
  • Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
  • Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
  • Availability of archival tumor tissue (core biopsy or surgical tumor blocks) for analysis. Sites will be asked to submit archival tissue (subjects may start the study if tissue is available at an outside hospital, but not yet requested or received).

Who cannot join

  • Patients will not be eligible for inclusion in this study if any of the following criteria apply:
  • Women who are pregnant or lactating and men.
  • Patients under age of 18
  • Prior use of abemaciclib or elacestrant (use of other cdk4/6 inhibitors are allowed)
  • The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • The patient has active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
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  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Wome who are pre-menopausal (women with chemically induced menopause are eligible).
  • More than two seizures in the last 4 weeks.
  • Have uncontrolled serious medical or psychiatric illness.
  • Have any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting. Baseline grade 2 or greater diarrhea.
  • Have an additional malignancy diagnosed within 5 years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ.
  • Patients may not be receiving any other investigational agents. A washout period of 14 days is required for all prior anti-cancer therapies.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

Other trials in United States

About this study

Official title: Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting.

Read the detailed description

This is a multi-institutional, Phase Ib/II study in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting. Single agent abemaciclib at a dose of 150 mg twice a day and elacestrant at a dose of 400mg / day will be administered to all patients, with allowances for up to 2 dose reductions due to treatment related toxicities. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0. After accrual of first 10 patients, the accrual will be halted and safety analysis (phase IB) will be performed. If response to the combination therapy will be documented in 2 or less patients accrual will be stopped. If at least 3 patients will have a documented response to therapy, accrual will continue to complete Stage 2

Conditions
Breast Cancer
Being tested
Abemaciclib, Elacestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called Verzenio

    taken orally

  • ElacestrantDrug

    taken orally

Study groups in NCT04791384
Study groupRoleWhat they receive
Abemaciclib/ElacestrantExperimentalAbemaciclib and Elacestrant combination
Receives: Drug: Abemaciclib; Drug: Elacestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of patients in Phase 1b part of the study with any adverse events (AE).

    To determine the safety and tolerability of the abemaciclib and elacestrant combination. We will assess the incidence, nature and severity of all adverse events (AE) that occur on or after C1D1 of therapy, AE severities will be classified using the CTCAE criteria.

    Measured: 1.5 years

  2. Assess the efficacy of the drug combination abemaciclib and elacestrant.

    Determine the overall intracranial response rate (OIRR; complete and partial response) and clinical benefit rate (CBR) as defined by brain metastasis response criteria (RANO-BM) in women with HR+ / Her2- breast cancer using the sum of study participants who experience complete response or partial response within 24 weeks or less. This assessment will look at tumor responses conducted before patients start treatment, at timepoints while receiving treatment, and at treatment end.

    Measured: The whole study- 2.5 years

Secondary outcomes (3)

  1. Evaluate tumor response rates of treatment with abemaciclib and elacestrant combination.

    Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. tumor responses conducted before patients start treatment, at timepoints while they receive treatment, and when their treatment ends, will be evaluated.

    Measured: 2.5 years

  2. Evaluate duration of tumor response rates of treatment with abemaciclib and elacestrant combination.

    Duration of intracranial benefit rate will be measured per the response assessment in neuro-oncology brain metastases (RANO-BM) for the time of participation in the study.

    Measured: 2.5 years

  3. The percentage of patients to complete the study.

    Study participants will be followed for the duration of their participate in the study for overall survival.

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start21 Apr 2022
  3. Primary completion16 Sep 2024
  4. Study completion17 Sep 2024

Why it stopped: Study was terminated due to delayed recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04791384
Sponsor's protocol ID
Lilly-I3Y-US-I026
Status last verified
Mar 2026
First submitted
30 Dec 2020
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Abemaciclib and Elacestrant in people with Breast Cancer, run by Criterium, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to delayed recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of patients in Phase 1b part of the study with any adverse events (AE). (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04791384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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