left-arrow right-arrow pinterest facebook google_plus linkedin

SWOG S1207 

e3 Breast Cancer Study – evaluating everolimus with endocrine therapy

Status:

Recruiting | Phase III

Official 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

Study Purpose: 

To determine if treatment with everolimus plus hormone treatment (after usual care of chemotherapy, surgery, and radiation) will prevent or lengthen the amount of time to recurrence.

Interventions:    

  • Targeted Therapy: Everolimus (Afinitor, Zortress) or Placebo  
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I:  Everolimus 20 mg oral pill daily x 1 year (along with MD choice of endocrine therapy)
  • ARM II:  Placebo oral pill daily x 1 year (along with MD choice of endocrine therapy)

After completion of study therapy, patients are followed up every 6 months for 2 years, then annually thereafter.

Key Participation Requirements

Gender: 

Male or Female

Age: 

19 years and older

Diagnosis: 

Breast cancer patients who have had surgery and whose cancer has higher risk features (i.e. – positive lymph nodes, high Oncotype DX/MammaPrint score, high grade, and/or large size)

Marker Status: 

Must be ER and/or PR positive and Her-2 negative

Prior Therapy: 

Must have had surgery and completed chemotherapy (before or after surgery). May or may not have had radiation.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

SWOG S1207 

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!