Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With ER+Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With ER+Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.
This is a three-arm, randomized, open label, multi-center phase II study investigating the
combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg
daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients
with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or
progression on letrozole or anastrozole. The reference therapy (control arm) used in the
course of this trial is the combination arm of everolimus plus exemestane. The
investigational therapies in the context of this study are everolimus monotherapy and
capecitabine monotherapy. All treatments will be taken orally until disease progression,
intolerable toxicity or withdrawal of patient's informed consent. Patients will be randomly
assigned with equal allocation to one of the treatment arms:
1. Exemestane (25mg daily) in combination with everolimus (10mg daily)
2. Everolimus (10mg daily)
3. Capecitabine (1250mg/m2 twice daily) orally for two weeks, followed by a one week rest
period in 3-weeks cycles.
Treatment assignment will be stratified by the presence of visceral disease (yes vs. no).
Visceral refers to lung, liver, heart, ovary, spleen, kidney, adrenal gland, malignant
pleural or pericardial effusion or malignant ascites.
Inclusion Criteria:
-Women with locally advanced, recurrent, or metastatic breast cancer along with
confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least
one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension
(CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in
the absence of measurable disease as defined above
Exclusion Criteria:
-Patients who received more than one chemotherapy line. Patients with only non-measurable
lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment
with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Description:
Once 150 PFS events have occured (determined by local assessment). To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
Outcome Time Frame:
28 months after first patient randomized or once 150 PFS have occurred
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001Y2201
NCT ID:
NCT01783444
Start Date:
February 2013
Completion Date:
April 2015
Related Keywords:
- Breast Cancer
- Estrogen receptor positive, locally advanced, metastatic breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD | Fort Worth, Texas 76104 |
| Glacier View Research Institute - Cancer SC | Kalispell, Montana 59901 |
| Tulsa Cancer Institute | Tulsa, Oklahoma 74136 |
| Florida Cancer Specialists Dept of Onc | Fort Myers, Florida 33901 |
| Eastern Maine Medical Center Research Center SC | Bangor, Maine 04401 |
| Long Beach Memorial Medical Carer SC | Long Beach, California 90808 |
| University of California at Los Angeles Mattel Children's Hospital | Los Angeles, California 90095 |
| Sharp Memorial Hospital SharpClinicalOncologyResearch | San Diego, California 92123 |
| Florida Cancer Specialists Dept of Oncology | Fort Myers, Florida 33901 |
| St. Lukes Hospital Mountain State Tumor Institute Dept of Oncology | Boise, Idaho 83712 |
| Stormont Vail Healthcare - Cotton-O'Neil Clinic Dept of Oncology | Topeka, Kansas 66606 |
| Carroll Regional Cancer Center | Westminster, Maryland 21157 |
| Beth Israel Deaconess Medical Center Dept of Oncology | Boston, Massachusetts 02215 |
| Lahey Clinic Dept of Lahey Clinic (2) | Burlington, Massachusetts 01805 |
| Newton Wellsley Hospital SC | Newton, Massachusetts 02462 |
| Trinitas Comprehensive Cancer Center SC | Elizabeth, New Jersey 07207 |
| Hackensack University Medical Center Dept of Oncology | Hackensack, New Jersey 07601 |
| University of Medicine and Dentistry of New Jersey SC | Newark, New Jersey 07101 |
| Richmond University Medical Center SC | Staten Island, New York 10310 |
| Oncology/Hematology Care, Inc. SC | Cincinnati, Ohio 45242 |
| The Jones Clinic SC | Germantown, Tennessee 38138 |
| University of Tennessee Cancer Center SC | Knoxville, Tennessee 27920-6969 |
| Sarah Cannon Research Institute SC (2) | Nashville, Tennessee 37203 |
| Northwest Medical Specialties SC | Tacoma, Washington 98405 |
