Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

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 a

Trial Details

NCT ID

NCT05696626

Phase

PHASE3

Sponsor

LeonaBio

Status

RECRUITING

Cancer Type

ER/PR Positive (Hormone Receptor Positive) Breast Cancer

Interventions

Lasofoxifene in combination with abemaciclib
Fulvestrant in combination with abemaciclib

Locations (sample)

Scottsdale, Arizona, United States|33.50921,-111.89903
Tucson, Arizona, United States|32.22174,-110.92648
Santa Rosa, California, United States|38.44047,-122.71443
Jacksonville, Florida, United States|30.33218,-81.65565
Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

Pre- or postmenopausal women or men.
Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palb…
Histological or cytological confirmation of ER+/HER2 - disease
No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.

For full eligibility, visit ClinicalTrials.gov.

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