BREAST: ADJUVANT: ER/PR+: CDK4/6: NATALEE

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

Title
Novartis CLEE011O12301C: NATALEE Breast
Study Title

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

Site Link
Malignancy
Breast cancer, Invasive breast cancer, BC
Stage
Disease Setting
Adjuvant/Curative
Line Of Therapy
Aduvant
Investigational Agent
Ribociclib
Drug Class
CDK4/6 inhibitor
PI
Lee Schwartzberg, MD
Sponsor
Novartis Pharmaceuticals
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Positive for ER and/or PgR
  • HER2 negative
  • Patient has had surgical resection where tumor was removed completely with negative margins
  • Anatomic Stage II or III
  • Completed neoadjuvant or adjuvant chemotherapy (if indicated)
  • Completed adjuvant XRT (if indicated)
  • Plan to treat pt with endocrine tx for 5 years
  • No prior CDK4/6 inhibitor
  • No prior tamoxifen, ralixofene, or AIs for chemoprevention
  • No prior tx with anthracycline at cumulative doses of 450mg/m2 or more
  • No distant metastatic disease
  • No other cancer within 2 years of study enrollment
  • No known HIV/HBV/HCV
  • No clinically significant cardiac disease
Objective
  • Primary: Invasive Disease Free Survival (IIDFS)
  • Secondary: RFS, distant DFS, OS, QOL, safety
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
ER or PR positive (HR+), adenocarcinoma
Dosing Frequency
Control Agents
endocrine therapy
Study Protocol
Randomized
Yes
X