Phase II Open Label Study of Everolimus (RAD001) in Combination With Letrozole in the Treatment of Post Menopausal Women With Locally Advanced or Metastatic Breast Cancer Women With Estrogen Receptor Positive After Failure of Tamoxifen and or Anestrozole or Examestane.
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Postmenopausal Women,, Locally Advanced or Metastatic Breast Cancer
Female
Postmenopausal Women,, Locally Advanced or Metastatic Breast Cancer
Trial Information
Phase II Open Label Study of Everolimus (RAD001) in Combination With Letrozole in the Treatment of Post Menopausal Women With Locally Advanced or Metastatic Breast Cancer Women With Estrogen Receptor Positive After Failure of Tamoxifen and or Anestrozole or Examestane.
Inclusion Criteria:
- 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:
1. Recurrence while on, or within 12 month of end of, adjuvant treatment with
Tamoxifen , Anastrozole, or Exemestane.
2. Recurrence while on, or within 24 month of end of, adjuvant treatment with
Letrozole.
3. Progression while on Tamoxifen, Anastrozole or Exemestane treatment for
locally advanced or metastatic breast cancer.
Exclusion Criteria:
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate (ORR)
Outcome Description:
imaging every 12 weeks
Outcome Time Frame:
until 1st progression
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001JIL05
NCT ID:
NCT01231659
Start Date:
August 2011
Completion Date:
June 2013
Related Keywords:
- Postmenopausal Women,
- Locally Advanced or Metastatic Breast Cancer
- RAD001 (Everolimus)
- Letrozole
- Breast cancer
- Metastatic Breast cancer
- Estrogen receptor positive
- Failure of Tamoxifen
- Anastrozole or Examestane
- Breast Neoplasms
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