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

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior 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.

Key facts

Study ID

NCT00863655

Run by

Novartis Pharmaceuticals

People needed

724

Starts

2009-06-03

Expected to finish

2014-12-04

Last updated by the study team

2017-05-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 clinical 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 as defined above.

You may not qualify if…

• HER2-overexpressing patients
• Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
• Patients who received more than one chemotherapy line for Advanced Breast Cancer.
• Previous treatment with exemestane or mTOR inhibitors.
• Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
• Radiotherapy within four weeks prior to randomization
• Currently receiving hormone replacement therapy,
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Highlands Oncology Group DeptofHighlandsOncologyGrp(2) — Fayetteville, Arkansas, United States
• Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C — Anaheim, California, United States
• Comprehensive Blood and Cancer Center Dept. of CBCC (3) — Bakersfield, California, United States
• Cancer Care Associates Dept.ofCancerCareAssoc. (2) — Fresno, California, United States
• Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc — Grass Valley, California, United States
• Scripps Clinic SC — La Jolla, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 — Los Angeles, California, United States
• Sharp Memorial Hospital SharpClinicalOncologyResearch — San Diego, California, United States
• University of California San Francisco UCSF Medical Center — San Francisco, California, United States
• Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ — Santa Monica, California, United States
• St Joseph Heritage Healthcare Dept. of RRMG (4) — Santa Rosa, California, United States
• Comprehensive Cancer Center - Boca Raton Deerfield Beach — Boca Raton, Florida, United States
• Florida Cancer Research Institute — Davie, Florida, United States
• Florida Cancer Specialists DeptofFloridaCancerSpecialists — Fort Myers, Florida, United States
• Memorial Hospital Memorial Cancer Institute — Hollywood, Florida, United States
• MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2) — Orlando, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Florida Medical Clinic PA Dept.ofFloridaMedicalClinic — Zephyrhills, Florida, United States
• Georgia Cancer Specialists. Drug Ship — Decatur, Georgia, United States
• Rush University Medical Center Study Coordinator — Chicago, Illinois, United States
• Oncology Specialists, SC Dept.of Oncology Specialists — Park Ridge, Illinois, United States
• Hematology Oncology of Indiana — Indianapolis, Indiana, United States
• Horizon Oncology Center — Lafayette, Indiana, United States
• Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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