Study Comparing Lasofoxifene and Abemaciclib with Fulvestrant and Abemaciclib for Advanced ER+/HER2- Breast Cancer with ESR1 Mutation

Sponsor: Sermonix Pharmaceuticals Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05696626

Provider View

This clinical trial is testing two different drug combinations to see which is more effective and safe for treating advanced estrogen receptor positive (ER+)/HER2 negative breast cancer with an ESR1 mutation in patients who have already tried other treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness and safety of two drug combinations for treating advanced ER+/HER2- breast cancer with an ESR1 mutation. Participants will receive either lasofoxifene and abemaciclib or fulvestrant and abemaciclib. The study aims to find out which combination works better in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Pre- or postmenopausal women or men.
  • Have advanced ER+ breast cancer that has progressed after treatment with palbociclib or ribociclib.
  • Confirmed ER+/HER2- breast cancer through lab tests.
  • No cancer progression for at least 6 months on previous treatment.
  • Have at least one ESR1 mutation in cancer cells, confirmed by blood or tissue tests.
  • Have advanced breast cancer with measurable or non-measurable lesions.
  • May have had one chemotherapy treatment for advanced cancer but must have recovered from side effects.
  • Good overall health with a performance score of 0 or 1.
  • Adequate organ function.
  • Able to swallow tablets.
  • Brain metastases allowed if they are asymptomatic, treated, not requiring steroids, and stable for over 3 months.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Lung cancer spread causing breathing issues.
  • History of severe lung disease from previous treatments.
  • Need for immediate chemotherapy due to severe symptoms.
  • Previous progression on abemaciclib, fulvestrant, or similar drugs.
  • Allergic to fulvestrant or its ingredients.
  • Recent radiotherapy, except for pain relief or bone protection.
  • Known genetic mutations that may cause resistance to treatment.
  • History of heart rhythm issues or long QT syndrome.
  • History of blood clots or clotting disorders.
  • Conditions increasing risk of blood clots, like severe heart failure.
  • Taking certain medications that affect drug metabolism.
  • Significant health issues affecting study participation.
  • Active infections requiring IV treatment.
  • Known HIV, hepatitis B, or hepatitis C infection.
  • Other cancers within the last 5 years, except certain skin cancers.
  • Positive pregnancy test (if premenopausal).
  • Unwilling to use contraception if sexually active.
  • Breastfeeding women.
  • History of not following medical advice.
  • Unwilling or unable to follow study protocol.
  • Participation in another clinical trial within the last 30 days.

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