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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05696626
Trial Phases:	Phase III	Protocol IDs:	SMX 22-002 (primary) NCI-2023-09871
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Sermonix Pharmaceuticals Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05696626

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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