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A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria:

- Adult Women (≥ 18 years old).

- Histologically or cytologically confirmed invasive breast carcinoma with local
recurrence or radiological evidence of metastatic disease.

- Must have at least one lesion that can be accurately measured or bone lesions in the
absence of measurable disease.

- HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization

- Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant
treatment is allowed but should be discontinued > 12 months prior to randomization.

- Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic
settings) is allowed but should be discontinued at randomization. Patients treated
with bisphosphonates at entry or who start bisphosphonates during study may continue
this therapy during protocol treatment.

- Documentation of negative pregnancy test.

Exclusion Criteria:

- Prior mTOR inhibitors for the treatment of cancer.

- Other anticancer therapy for locally advanced or metastatic breast cancer except for
prior hormonal therapy.

- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
effusion, ascites, etc).

- Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization

- History of central nervous system metastasis.

- Impairment of gastrointestinal (GI) function or GI disease or active ulceration of
the upper gastrointestinal tract.

- Serious peripheral neuropathy.

- Cardiac disease or dysfunction.

- Uncontrolled hypertension.

- HIV.

- Pregnant, Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first.

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • HER2+
  • mTOR
  • everolimus
  • RAD001
  • first line
  • metastatic
  • locally advanced
  • Breast Neoplasms



Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Ventura County Hematology and OncologyOxnard, California  93030
Central Hematology Oncology Medical GroupAlhambra, California  91801
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)Fayetteville, Arkansas  72703
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.Mobile, Alabama  36688
Ironwood Cancer and Research CentersChandler, Arizona  85224
Comprehensive Blood and Cancer Center Dept. of CBCC (2)Bakersfield, California  93309
St. Jude Heritage Medical Group Virginia Crosson Cancer CenterFullerton, California  92835
Cancer Care Associates Medical Group Dept. of CCARedondo Beach, California  90277
Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/OncSanta Barbara, California  93105
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)Greenwood Village, Colorado  
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)Fort Myers, Florida  33901
Central Indiana Cancer Centers CICC - East (3)Indianapolis, Indiana  46227
Kansas City Cancer Center Dept. of KCCCOverland Park, Kansas  66210
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)Omaha, Nebraska  68198
Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)New York, New York  10003
New York Oncology Hematology, P.C. NYOH AmsterdamTroy, New York  12180
Northwest Cancer Specialists Vancouver Cancer Center (3)Portland, Oregon  97210
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)Nashville, Tennessee  37203
Texas Oncology, P.A. Charles A. Sammons Cancer CtrDallas, Texas  75246
Texas Oncology, P.A. Central Austin Cancer CenterDallas, Texas  75251
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)Tyler, Texas  75702
Virginia Oncology Associates Dept. of VOANorfolk, Virginia  23502
Virginia Cancer Institute VCI (3)Richmond, Virginia  23230
University of California at Los Angeles Dept. of UCLALos Angeles, California  90095