Clinical Trial

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

MOA: PF-07248144 is a KAT6A inhibitor

Key Eligibility Criteria:

• HR+ /HER2-negative (IHC 0/1+, IHC 2+ & ISH-) LA/met BC
• Must have had prior CDK4/6i + ET (adv/met setting) OR adjuvant CDK4/6i + ET with documented PD/recurrence <12 months after last dose of CDK4/6i
• Must have had 1 prior systemic tx:
  • ET monotherapy in adv/met OR
  • Rechallenge tx with CDK4/6i + ET adv/met OR
  • Targeted therapy for ESR1 or BRCA1/2
  • Prior fulvestrant/exemestane is allowed but not required
  • Prior chemo, including ADCs, in adv/met setting are excluded
• >2 prior lines of systemic tx in adv/met setting are excluded
• Measurable disease or bone only disease by RECIST v1.1
• Tissue alterations in PIK3CA/AKT1/PTEN (local F1CDx assay) are excluded
  • Prior target tx for 1 or more of these alterations are excluded
• FFPE tumor tissue must be provided
• Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis or leptomeningeal disease excluded