Lasofoxifene and Abemaciclib vs Fulvestrant and Abemaciclib for Breast Cancer
(ELAINEIII Trial)
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on strong CYP3A4 inhibitors or inducers, as these can affect how the trial drugs work.
What data supports the effectiveness of the drug combination of Lasofoxifene and Abemaciclib vs Fulvestrant and Abemaciclib for breast cancer?
Research shows that Abemaciclib, when combined with endocrine therapy like Fulvestrant, significantly improves progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer. This suggests that Abemaciclib is effective in treating this type of breast cancer, which may support its use in combination with other drugs like Lasofoxifene.12345
Is the combination of Lasofoxifene and Abemaciclib safe for breast cancer treatment?
What makes the drug combination of Lasofoxifene and Abemaciclib unique for breast cancer treatment?
The combination of Lasofoxifene and Abemaciclib is unique because it pairs a selective estrogen receptor modulator (Lasofoxifene) with a CDK4/6 inhibitor (Abemaciclib), potentially offering a novel approach to treating hormone receptor-positive, HER2-negative breast cancer by targeting both estrogen receptors and cell cycle regulation.12357
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Fulvestrant
- Lasofoxifene
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
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Who Is Running the Clinical Trial?
Sermonix Pharmaceuticals Inc.
Lead Sponsor