An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer
18 Years
N/A
Female
Hormone Receptor Positive Breast Cancer
Trial Information
An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer
Inclusion Criteria:
- Patients 18 years old or greater
- Patients with metastatic or locally advanced, unresectable breast cancer not amenable
to curative treatment by surgery or radiotherapy
- Histological or cytological confirmation of estrogen-receptor positive (ER+) human
epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Postmenopausal women
- No prior treatment for metastatic breast cancer
Exclusion Criteria:
- Patients with only non-measurable lesions other than bone metastases (e.g., pleural
effusion, ascites, etc)
- Patients who have received prior hormonal or any other systemic therapy for
metastatic breast cancer.
- Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the
case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must
have completed therapy at least 1 year prior to study enrollment.
- Previous treatment with mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
- Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients progression-free after completion of 1st line treatment (everolimus + letrozole)
Outcome Description:
In this study Progression free survival is defined as the time from the date of receiving first line study treatment (everolimus + letrozole) to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last adequate tumor assessment.
Outcome Time Frame:
12 months after last patient recruited
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001Y24135
NCT ID:
NCT01698918
Start Date:
March 2013
Completion Date:
February 2016
Related Keywords:
- Hormone Receptor Positive Breast Cancer
- metastatic breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Cone Health Cancer Center | Greensboro, North Carolina |
| Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City, Utah 84103 |
| Banner MD Anderson Cancer Center | Gilbert, Arizona 85234 |
| Saint Barnabas Medical Center CancerCenter of Saint Barnabas | Livingston, New Jersey 07039 |
| Mercy Medical Research Institute SC | Manchester, Missouri 63021 |
| Oncology Specialists, SC Dept.of Oncology Specialists | Park Ridge, Illinois 60068-0736 |
| University of Alabama Comprehensive Cancer Center SC | Birmingham, Alabama 35294 |
| Loma Linda University Loma Linda | Loma Linda, California 92354 |
| Breastlink Medical Group Dept. of BreastlinkResearchGrp | Long Beach, California 90806 |
| Northwestern University SC | Chicago, Illinois 60611 |
| Norton Healthcare, Inc. SC | Louisville, Kentucky 40202 |
| Holy Cross Hospital SC | Silver Spring, Maryland 20910 |
| Baystate Medical Center SC | Springfield, Massachusetts 00119 |
| Methodist Cancer Center SC-1 | Omaha, Nebraska 68114 |
| University of New Mexico Hospital SC | Albuquerque, New Mexico 87106 |
| Columbia University Medical Center- New York Presbyterian Columbia | New York, New York 10032 |
| Geisinger Health System GHS | Danville, Pennsylvania 17822-2170 |
| East Texas Hematology Clinic SC | Lufkin, Texas 75904 |
| Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SC-3 | Seattle, Washington 98109-1023 |
