A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

There are no treatments specifically approved after recurrence or progression on a NSAI. In light of the need for new treatment options for postmenopausal women after failure of prior non steroidal aromatase inhibitors (NSAI) therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Everolimus
  • drug : Exemestane
  • drug : Placebo

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Adult women (? 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. - Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer - Postmenopausal women. - Disease refractory to non steroidal aromatase inhibitors (NSAI), - Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization. - Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease - Adequate bone marrow and coagulation function - Adequate liver and renal function - ECOG Performance Status = 2 or less

External Links

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Contact information

Primary Contact:

Mary Chen 6507238686

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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