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
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
SMX 22-002 (primary)
NCI-2023-09871
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.
Eligibility
- 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
- Adequate organ function
- Able to swallow tablets
- Brain metastases are allowed only if the following 4 parameters hold:
- Asymptomatic,
- Definitively treated (e.g., radiotherapy, surgery),
- Not requiring steroids up to 4 weeks before study treatment initiation, AND
- Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI).
- Able to understand and voluntarily sign a written informed consent before any screening procedures.
Treatment Sites in Georgia
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