At a glance
ClinicalIndex Comparison Record- ✓Pre- or postmenopausal women or men
- ✓Metastatic ER+ breast cancer with progression on AI plus palbociclib or ribociclib as first hormonal treatment
- ✓ER+/HER2- disease confirmed histologically or cytologically
- ✓No progression for at least 6 months on AI/CDKi combination
- ✕Lymphangitic carcinomatosis involving the lung
- ✕History of Grade 3 or 4 interstitial lung disease on previous therapy
- ✕Visceral crisis requiring cytotoxic chemotherapy
- ✕Prior progression on abemaciclib, fulvestrant, or other SERD therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
In Brief
A Phase 3 clinical trial evaluating Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib for Metastatic Breast Cancer. Currently recruiting, targeting 600 participants across 224 sites in 17 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day