Status:
COMPLETED
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Postmenopausal Women
Locally Advanced Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression...
Detailed Description
Screening Period: Postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer whose disease was refractory to hormonal therapy and had a documented recurrence o...
Eligibility Criteria
Inclusion
- Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.
- Refractory disease to hormonal therapy is defined as:
- Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.
- Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.
- Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.
Exclusion
- Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.
- Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.
Key Trial Info
Start Date :
August 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01231659
Start Date
August 9 2011
End Date
April 30 2017
Last Update
March 26 2021
Active Locations (7)
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1
Novartis Investigative Site
Jerusalem, Israel, 91120
2
Novartis Investigative Site
Kfar Saba, Israel, 4428164
3
Novartis Investigative Site
Petah Tikva, Israel, 49100
4
Novartis Investigative Site
Ramat Gan, Israel, 52621