Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

Key facts

Study ID

NCT00876395

Run by

Novartis Pharmaceuticals

People needed

719

Starts

2009-09-10

Expected to finish

2017-10-23

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 positive).
• 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.
• Organ functions at time of inclusion.

You may not qualify if…

• 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,

Where it is running

• Ironwood Cancer and Research Centers — Chandler, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Comprehensive Blood and Cancer Center Dept. of CBCC (2) — Bakersfield, California, United States
• St. Jude Heritage Medical Group Virginia Crosson Cancer Center — Fullerton, California, United States
• University of California at Los Angeles Dept. of UCLA — Los Angeles, California, United States
• Ventura County Hematology and Oncology — Oxnard, California, United States
• Cancer Care Associates Medical Group Dept. of CCA — Redondo Beach, California, United States
• Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation Onc Dept — Santa Maria, California, United States
• Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3) — Greenwood Village, Colorado, United States
• Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) — Fort Myers, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Central Indiana Cancer Centers CICC - East (3) — Indianapolis, Indiana, United States
• Kansas City Cancer Center Dept. of KCCC — Overland Park, Kansas, United States
• University of Nebraska Medical Center Unv Nebraska Med Ctr (2) — Omaha, Nebraska, United States
• New York Oncology Hematology NYOH Amsterdam — Albany, New York, United States
• Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2) — New York, New York, United States
• Northwest Cancer Specialists Vancouver Cancer Center (3) — Portland, Oregon, United States
• Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5) — Nashville, Tennessee, United States
• Texas Oncology Charles A. Sammons Cancer Ctr — Dallas, Texas, United States
• Texas Oncology P A SC-Austin — Dallas, Texas, United States
• Tyler Cancer Center Dept.ofTylerCancerCtr. (2) — Tyler, Texas, United States
• Virginia Oncology Associates SC — Norfolk, Virginia, United States
• Virginia Cancer Institute VCI (3) — Richmond, Virginia, United States
• University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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