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CDK4/6 Inhibitor

Lasofoxifene and Abemaciclib vs Fulvestrant and Abemaciclib for Breast Cancer (ELAINEIII Trial)

Phase 3
Recruiting
Research Sponsored by Sermonix Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue
Pre- or postmenopausal women or men
Must not have
Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment)
Sexually active premenopausal women and men unwilling to use double-barrier contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 3 years
Awards & highlights

Summary

This trial will explore a new combination of drugs to treat breast cancer in people who have previously received other treatments.

Who is the study for?
This trial is for pre- or postmenopausal women and men with advanced ER+/HER2- breast cancer that has worsened on certain treatments. They must have specific ESR1 mutations, be able to swallow pills, and have good organ function. Brain metastases are okay if stable and untreated by steroids. People can't join if they've had severe lung disease from treatment, need urgent chemo, progressed on similar drugs before, or have conditions increasing blood clot risks.
What is being tested?
The study compares the effectiveness of lasofoxifene combined with abemaciclib versus fulvestrant combined with abemaciclib in treating breast cancer with an ESR1 mutation. Participants will either take lasofoxifene orally daily plus twice-daily abemaciclib or get monthly fulvestrant injections plus twice-daily abemaciclib.
What are the potential side effects?
Potential side effects include those common to hormone therapies like hot flashes and joint pain, as well as possible liver issues, fatigue, low white blood cell counts (increasing infection risk), diarrhea from abemaciclib; lasofoxifene may also increase the risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific mutation in the ESR1 gene.
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I am a woman or man, regardless of my menopause status.
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I am fully active or have some restrictions but can still care for myself.
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My breast cancer has spread and can be measured or seen on scans.
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I can swallow pills.
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My cancer is ER positive and HER2 negative.
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My ER+ breast cancer has worsened on my first hormone therapy for its advanced stage.
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My advanced breast cancer hasn't worsened in 6 months while on AI/CDKi treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an active infection requiring IV antibiotics or antifungals.
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I am sexually active, can still have children, and won't use two forms of birth control.
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I am taking medication that strongly affects liver enzymes.
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My cancer progressed despite treatment with specific hormone therapies.
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I have had severe lung issues due to past treatments.
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My cancer has spread to the lymph vessels in my lungs.
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I need strong chemotherapy for a severe crisis in my organs.
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I do not have any major health issues that could affect my safety in the study.
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I do not have conditions like severe heart failure or long-term immobility that increase my risk for blood clots.
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I have had a blood clot in my lungs or veins, or I have a condition that increases my risk of blood clots.
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I am currently taking strong CYP3A4 inhibitor medications.
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I have been diagnosed with HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and within approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DoR) in subjects with an objective response
Incidence of Adverse Events (AEs) and Serious AEs
+5 more

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803
50%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
CONTUSION
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
HYPERTRIGLYCERIDAEMIA
10%
HERPES ZOSTER
10%
PNEUMONIA
10%
DRY MOUTH
10%
DYSPEPSIA
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
NAUSEA
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
PLATELET COUNT DECREASED
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Group II: Reference TherapyActive Control1 Intervention
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.

Find a Location

Who is running the clinical trial?

Sermonix Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05696626 — Phase 3
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05696626 — Phase 3
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696626 — Phase 3
~168 spots leftby Jun 2025
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