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Clinical Trials Details

An Open, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

Location: Carle Cancer Center - Urbana
Body site or condition: Breast - Metastatic
Department: Cancer Research

SMX 18-001

This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an ESR1 mutation.---- The secondary objectives are to evaluate:-- 1.Clinical benefit rate (CBR) and Objective Response Rate (ORR)-- 2.Duration of response-- 3.Time to response-- 4.Overall Survival (OS)-- 5.Pharmacokinetics of lasofoxifene-- 6.Quality of life (QoL)-- 7.Safety of lasofoxifene-- 8.Response to various ESR1 mutation subtypes-- 9.The presence of the following mutations from tumor free DNA will be documented and part of an exploratory analysis:-- a.) erbb2 extracellular domain mutation 5310;-- b.) erbb2 kinase domain mutations V777, L755, and Exon 20 insertion;-- 3.all NF1 mutations that are truncating, frame shifting and nonsense or homozygous deletions; and-- 4.KRAS.

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