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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within approximately 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

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 2021 Phase 3 trial • 693 Patients • NCT02028507

73%

Palmar-plantar erythrodysesthesia syndrome

58%

Fatigue

56%

Diarrhea

38%

Hypertension

38%

Nausea

30%

Mucositis

29%

Vomiting

26%

Weight loss

26%

Weight gain

24%

Anorexia

20%

Nail disorder

17%

Back pain

16%

Hypothermia

15%

Constipation

15%

Abdominal pain

14%

Neutrophil count decreased

13%

Dizziness

13%

Upper respiratory infection

13%

Headache

11%

Dyspepsia

10%

Fever

10%

Obesity

10%

Dysgeusia

10%

Pain in extremity

Arthralgia

Bone pain

Anemia

Cough

Pruritus

Flu like symptoms

Pain

Alopecia

Thromboembolic event

Bone fracture

Gastrointestinal infection

Spinal cord compression

Febrile neutropenia

Hot flashes

Pancreatitis

Respiratory infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 20Eligibility criteria met