Clinical Trial

A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY (CO44657)

MOA: Giredestrant is an oral selective estrogen receptor degrader (SERD)

Key Eligibility Criteria:

• Locally advanced or metastatic ER+(≥1%)/HER2- BC
• Confirmed ESR1 mutation status [ESR1m vs ESR1nmd]
  • Central testing (F1LCDx)
• Relapsed on standard adjuvant ET with AI and/or SERM
  • On-treatment after ≥12 months
  • Off-treatment within 12 months of completion
  • If CDK4/6i, relapse ≥12 months since completion
• No prior tx in metastatic setting
• Measurable disease or evaluable bone-only disease per RECIST v1.1
• Prior tx w/ SERD, proteolysis tarting chimera, CERAN, novel SERM excluded