Other Mutations: ESR1

NCT04964934: Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

NCT04964934
Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+
Other Mutations: ESR1
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 3
Drug Category: Endocrine (Hormone Therapy, Serine-Threonine Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years to 130 Years (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patients must be currently on an aromatase inhibitor (e.g., letrozole or anastrozole) + CDK4/6 inhibitor (e.g., palbociclib/Ibrance or abemaciclib/Verzenio) +/- a luteinizing hormone-releasing hormone (LHRH agonist (e.g., Lupron, Zoladex) as the initial endocrine based treatment for advanced disease
Exclusions: Patients with known, active, uncontrolled, or symptomatic CNS metastases or leptomeningeal disease; Patients with prior treatment of AZD9833, investigational SERDs (selective estrogen receptor degraders), or fulvestrant
https://ClinicalTrials.gov/show/NCT04964934

NCT04432454: Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2‚àí Breast Cancer With an ESR1 Mutation

NCT04432454
Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+
Other Mutations: ESR1
Breast Cancer Tissue: 
Recruitment Status: Active, not recruiting
Phase 2
Drug Category: Endocrine (Hormone) Therapy, Serine-Threonine Kinase Inhibitor

Key Eligibility Criteria:

Gender: Female
Age: Child, Adult, Older Adult
Location of Metastases: 
Additional Notes: 
Exclusions: Patients with more than 2 endocrine treatment regimens for metastatic disease- see trial for details; Patients with more than one cytotoxic chemotherapy regimen for metastatic disease; Patients with symptomatic, unstable, untreated brain metastases- see trial for details
https://ClinicalTrials.gov/show/NCT04432454

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