Primary Objectives
To evaluate the progression free survival (PFS) 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.
Secondary Objectives
To evaluate the antitumor response of each drug regimen as characterized by:
• Objective response rate (ORR)
• Overall survival (OS)
• Clinical benefit rate (CBR)
• Duration of response (DoR) in subjects with an objective response
• Time to response (TTR) in subjects with an objective response
In addition, to determine the following for the study population:
• Time to cytotoxic chemotherapy
• Quality of life (QoL) using Functional Assessment of Cancer Therapy-Breast Cancer-Endocrine Subscale (FACT B-ES)
• Safety
- Category
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Trial status
Not yet recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
103661
Trial contact details
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Contact person
Kathryn Middleton
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Phone
07 3163 6166
What you need to know
Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation.
For more information, contact the study doctor.
