RecruitingPhase 3

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

United States500 participantsStarted 2023-10-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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 palbociclib or ribociclib as their first hormonal treatment for metastatic disease.
✓. 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.
✓. At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue.
✓. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
✓. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy.
✓. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

Exclusion criteria

What they're measuring

Progression free survival (PFS)

Timeframe: Within approximately 3 years

Trial details

NCT IDNCT05696626

SponsorLeonaBio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Simon Daggett - Senior Vice President, Clinical Operations

(909) 374-3793 clinicaltrials@leonabio.com

View on ClinicalTrials.gov More Metastatic Breast Cancer trials