USO 21173
A Phase 3, double-blind, randomized study to assess the efficacy and safety of switching to AZD9833 (an oral SERD) + CDK4/6 inhibitors (palbociclib or abemaciclib) vs continuing aromatase inhibitor + CDK4/6 inhibitors in patients with acquired ESR1 mutation without radiological progression during 1L treatment with AI + CDK4/6i for HR+/HER2- mBC-ctDNA guided early switch study (SERENA 6) (D8534C00001)
Disease Types: Breast Cancer Research
Eligibility Requirements:
-ER +/Her 2 - recurrent or metastatic breast cancer not amenable to surgery or radiation therapy with curative intent
-Currently on aromatase inhibitor (AI) letrozole or anastrozole + CDK4/6 inhibitor (palbociclib or abemaciclib) ± Luteinizing hormone-releasing hormone (LHRH) agonist as initial endocrine treatment for advanced disease
-No: known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease; evidence of severe or uncontrolled systemic diseases; known or family history of severe heart disease; previous treatment with investigational Selective estrogen receptor degraders (SERDs) or fulvestrant; persistent non-hematological toxicities (Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.
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