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

Sponsor: Sermonix Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03781063

Provider View

This clinical trial is testing whether the drug lasofoxifene is more effective than fulvestrant in treating advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation in women who have not responded to previous treatments.

Patient Parameters

Program Overview

This study is looking at how well lasofoxifene works compared to fulvestrant in women with advanced or metastatic estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has an ESR1 mutation. These women have seen their cancer progress despite treatment with an aromatase inhibitor and a CDK 4/6 inhibitor. The main goal is to see if lasofoxifene can help patients live longer without their cancer getting worse. The study will also look at other factors like overall survival, quality of life, and the safety of lasofoxifene.

Description

Lasofoxifene is a drug that has shown promise in preventing and treating breast cancer in lab studies. It has been effective in reducing the risk of ER+ breast cancer in women with osteoporosis. This study aims to see if lasofoxifene can be a better treatment option for women with advanced breast cancer that has a specific mutation (ESR1) and has not responded well to other treatments. Participants will be randomly assigned to receive either lasofoxifene or fulvestrant, a standard treatment, to compare their effectiveness. The study will monitor how long patients live without their cancer worsening, their overall survival, and any side effects. Participants will have regular check-ups and tests to track their progress.

Eligibility Criteria

Inclusion Criteria

  • Women who are premenopausal or postmenopausal.
  • Have advanced or metastatic ER+/HER2- breast cancer that has progressed after treatment with an aromatase inhibitor and a CDK 4/6 inhibitor.
  • Have a specific ESR1 mutation in their cancer cells.
  • Have not received more than one chemotherapy regimen for metastatic breast cancer.
  • Have good overall health and organ function.
  • Able to swallow tablets and willing to sign informed consent.

Exclusion Criteria

  • Previous use of certain cancer drugs like everolimus or PI3K inhibitors unless stopped for reasons other than cancer progression.
  • Cancer that has spread to the brain.
  • Severe lung involvement from cancer.
  • Need for immediate chemotherapy due to worsening cancer.
  • Recent radiation therapy unless for pain relief or bone protection.
  • History of heart rhythm problems or recent blood clots.
  • Significant other health issues that could affect safety or study participation.
  • Positive tests for HIV, hepatitis B, or untreated hepatitis C.
  • Recent history of other cancers, except for certain skin cancers or early-stage cervical cancer.
  • Uncontrolled high blood pressure.
  • Participation in another clinical trial within the last 30 days.

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