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Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor

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

ELAINEII Trial 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.Check my eligibility
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.See study design
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.

ELAINEII Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perinatal death
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DoR)
Objective response rate (ORR)
+3 more

ELAINEII 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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Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
2020. "Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04432454.
~1 spots leftby May 2024
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