West Cancer Center

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

Site Link

NCT01674140

Malignancy

Breast, early breast cancer

Stage

Stage 2

Disease Setting

Adjuvant, following chemotherapy

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01674140

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

Assessment Frequency Link

Path

Dosing Frequency

Daily

Control Agents

Standard endocrine therapy (Tamoxifen, goserelin, leuprolide, letrozole,, anastrazole, or exemestane)

Study Protocol

Randomized

Yes