SERENA-6: AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression
Condition: Breast Cancer
Sponsor: AstraZeneca
Full Title
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
Eligibility/Info
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 (SERD) AZD9833.
Contact
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.
