USO 25042

A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor (RLY-2608-102)

Disease Types: Breast Cancer Research

Eligibility Requirements:

• ER+, HER2-negative MBC
• PD on/after previous treatment for HR+/HER2- ABC
• 1-2 prior lines of ET (including fulvestrant/ SERD) AND 1 prior line of CDK4/6i
• (Neo)adjuvant count as prior line if PD occurred during/within 12 months of tx completion
• No more than 1 line of chemotherapy in the ABC setting
• Measurable disease per RECIST v1.1 or evaluable bone-only disease (at least 1 lytic or
lytic/blastic lesion measurable by CT or MRI)
• 1 or more oncogenic PIK3CA mutation in tissue or blood (local testing, confirmed by central
testing of ctDNA before randomization)
• Tumor tissue must be provided at screening
KEY EXCLUSIONS
• Concomitant activating AKT mutation, loss-of-function PTEN mutations, or loss of PTEN
leading to downstream PI3K activation
• Prior Immunotherapy, ADC, CDK2 or selective CDK4 inhibitors or any investigational tx
targeting CDKs
• Prior tx with PI3K, AKT, or mTOR inhibitors or any PI3K/AKT/mTOR pathway inhibitors
• Type I diabetes, or type 2 diabetes requiring antihyperglycemic medication
• Fasting plasma glucose ≥140 mg/dL, or HbA1C ≥7.0%
(≥53 mmol/mol)

For more details on this trial CLICK HERE .

Available at:

• Chesapeake
• Hampton (CarePlex)
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)
• Williamsburg