SWOG S1207

SWOG S1207 - 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.

Primary Objective: The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer.

Secondary Objectives:

a. To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival and distant recurrence-free survival in this patient population.

b. To evaluate the safety, toxicities and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and compare it with standard adjuvant endocrine therapy plus placebo in this patient population.

c. To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score, nodal status, or other commonly used prognostic factors.

Other Objectives:

a. To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population.

b. To collect specimens in order to evaluate biomarkers of therapeutic efficacy.

Eligibility Criteria:

  • Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, for whom standard adjuvant endocrine therapy is planned.
  • Patients must not have metastatic breast cancer (Stage IV disease).
  • Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging. A negative margin is defined as no evidence of tumor or DCIS at the line of resection. Additional operative procedures may be performed to obtain clear margins.
  • Patients must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection.
  • Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization.
  • Adequate lab values to be completed prior to registering for the trial.
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities, and the potential of this regimen to harm nursing infants.
  • Several other eligibility criteria that the Coordinator can discuss with you further if you possibly qualify for this trial.