Know Cancer

or
forgot password

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.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

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 & BDFort Worth, Texas  76104
Glacier View Research Institute - Cancer SCKalispell, Montana  59901
Tulsa Cancer InstituteTulsa, Oklahoma  74136
Florida Cancer Specialists Dept of OncFort Myers, Florida  33901
Eastern Maine Medical Center Research Center SCBangor, Maine  04401
Long Beach Memorial Medical Carer SCLong Beach, California  90808
University of California at Los Angeles Mattel Children's HospitalLos Angeles, California  90095
Sharp Memorial Hospital SharpClinicalOncologyResearchSan Diego, California  92123
Florida Cancer Specialists Dept of OncologyFort Myers, Florida  33901
St. Lukes Hospital Mountain State Tumor Institute Dept of OncologyBoise, Idaho  83712
Stormont Vail Healthcare - Cotton-O'Neil Clinic Dept of OncologyTopeka, Kansas  66606
Carroll Regional Cancer CenterWestminster, Maryland  21157
Beth Israel Deaconess Medical Center Dept of OncologyBoston, Massachusetts  02215
Lahey Clinic Dept of Lahey Clinic (2)Burlington, Massachusetts  01805
Newton Wellsley Hospital SCNewton, Massachusetts  02462
Trinitas Comprehensive Cancer Center SCElizabeth, New Jersey  07207
Hackensack University Medical Center Dept of OncologyHackensack, New Jersey  07601
University of Medicine and Dentistry of New Jersey SCNewark, New Jersey  07101
Richmond University Medical Center SCStaten Island, New York  10310
Oncology/Hematology Care, Inc. SCCincinnati, Ohio  45242
The Jones Clinic SCGermantown, Tennessee  38138
University of Tennessee Cancer Center SCKnoxville, Tennessee  27920-6969
Sarah Cannon Research Institute SC (2)Nashville, Tennessee  37203
Northwest Medical Specialties SCTacoma, Washington  98405