SERENA-6: AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression
Condition: Breast Cancer
D8534C00001: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor
Early switch to investigational oral selective estrogen receptor degrader (SERD) AZD9833 in combination with continued CDK4/6 inhibitor vs continued treatment with aromatase inhibitor in combination with CDK4/6 inhibitor
Study of ctDNA testing for the development of an ESR1 mutation of ER-positive, HER2-negative metastatic breast cancer patients that have been on treatment with a CDK4/6 inhibitor (abemaciclib or palbociclib) and an aromatase inhibitor (AI) for at least 6 months. Patients that develop an ESR1 mutation while on treatment will be randomized to either continue treatment with their current CDK4/6 inhibitor + AI or change the AI to investigational oral selective estrogen receptor degrader AZD9833.
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.