BREAST: Adjuvant: ER/PR+: HER2-; \"e3\"

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy

Title
SWOG 1207
Study Title

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy

Site Link
Malignancy
Breast, early breast cancer
Stage
Disease Setting
Adjuvant, following chemotherapy
Line Of Therapy
N/A
Investigational Agent
everolimus
Drug Class
MTOR inhibitor
PI
Lee Schwartzberg, MD
Sponsor
Southwest Oncology Group
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

High risk early breast cancer as defined as follows:

  • Post adjuvant chemo withTumor >2cm, N0, Oncotype Dx >25 or
  • Post adjuvantchemo with 1-3 positive nodes, OncDx >25 or
  • Post adjuvant chemo with >3 positive nodes or
  • Post neoadjuvant chemo with >3 positive nodes

HER2 negative, ER/PR positive
Completed standard neoadjuvant or adjuvant taxane or anthracycline therapy
No prior receipt of MTOR inhibitors
ECOG PS 0-2
Fasting cholesterol <300, TG <2.5x ULN
HIV positive allowed if controlled CD4 count and NOT on ART

Objective

Primary: Invasive Disease Free Survival; Secondary: OS, Safety, Role of Recurrence Score, Adherence

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Dosing Frequency

Daily

Control Agents
Standard endocrine therapy (Tamoxifen, goserelin, leuprolide, letrozole,, anastrazole, or exemestane)
Study Protocol
Randomized
Yes
X