Lasofoxifene + Abemaciclib for Breast Cancer (ELAINEII Trial)

Phase 2

Waitlist Available

Research Sponsored by Sermonix Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat ER+/HER2- breast cancer that has progressed despite hormonal treatment. Lasofoxifene and abemaciclib will be given to see if the combination is safe and well tolerated.

Who is the study for?

This trial is for pre- and postmenopausal women with advanced or metastatic ER+/HER2- breast cancer that worsened after hormonal therapy. They must have specific ESR1 mutations, received one chemo regimen, and meet certain health criteria. Exclusions include significant other illnesses, recent serious blood clots, active infections requiring IV antibiotics, and certain drug interactions.

What is being tested?

The study tests a combination of lasofoxifene and abemaciclib in women whose breast cancer has progressed despite treatment. It's an open-label trial where all participants receive the drugs to assess safety and tolerability.

What are the potential side effects?

Possible side effects may include hot flashes from lasofoxifene and diarrhea, fatigue, low white blood cell counts leading to infection risk from abemaciclib. Other reactions can vary based on individual health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Perinatal death

Secondary study objectives

Duration of response (DoR)

Progression free survival (PFS)

Time to response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Women who have locally advanced or metastatic ER+/HER2- breast cancer and disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation

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