Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 af...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2014
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT00863655
Start Date
June 3 2009
End Date
December 4 2014
Last Update
May 2 2017
Active Locations (200)
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1
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
2
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, United States, 72703
3
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, United States, 92807
4
Comprehensive Blood and Cancer Center Dept. of CBCC (3)
Bakersfield, California, United States, 93309