Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer

In brief

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Key facts

Study ID

NCT01007942

Run by

Novartis Pharmaceuticals

People needed

569

Starts

2009-10-01

Expected to finish

2015-06-01

Last updated by the study team

2017-04-05

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
• HER2+ status defined as IHC 3+ staining or in situ hybridization positive
• Patients with resistance to trastuzumab
• Prior taxane therapy
• Patients with an ECOG performance status of 0 - 2
• Patients with measurable disease as per RECIST criteria
• Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
• Patients must meet laboratory criteria defined in the study within 21 days prior to randomization

You may not qualify if…

• Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer
• More than three prior chemotherapy lines for advanced disease.
• Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
• Peripheral neuropathy ≥ grade 2 at randomization
• Active cardiac disease
• History of cardiac dysfunction
• Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
• Known hypersensitivity to any study medication
• Breastfeeding or pregnant

Where it is running

• University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3) — Tucson, Arizona, United States
• University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer — La Jolla, California, United States
• Rocky Mountain Cancer Centers RMCC — Greenwood Village, Colorado, United States
• Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3) — Washington D.C., District of Columbia, United States
• Comprehensive Cancer Center - Boca Raton Deerfield Beach — Boca Raton, Florida, United States
• Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr — Boca Raton, Florida, United States
• Florida Cancer Specialists DeptofFloridaCancerSpecialists — Fort Myers, Florida, United States
• Memorial Hospital Memorial Cancer Institute — Hollywood, Florida, United States
• MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2) — Orlando, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) — Atlanta, Georgia, United States
• North Shore University Health System NSU — Evanston, Illinois, United States
• Kansas City Cancer Center KCCC- South (2) — Overland Park, Kansas, United States
• Maryland Oncology Hematology — Owning Mills, Maryland, United States
• Park Nicollet Institute Dept. of Park Nicollet — Saint Louis Park, Minnesota, United States
• St. Louis University Cancer Center SLU Cancer Center — St Louis, Missouri, United States
• University of Nebraska Medical Center Unv Nebraska Med Ctr (2) — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4) — Las Vegas, Nevada, United States
• Nevada Cancer Institute Dept. of Nevada Cancer (3) — Las Vegas, Nevada, United States
• Overlook Hospital - Carol G Simon Cancer Center Carol G Simon — Summit, New Jersey, United States
• Clinical Research Alliance Dept.ofArenaOncologyAssoc(2) — Lake Success, New York, United States
• Duke University Medical Center Dept. of DUMC (2) — Durham, North Carolina, United States
• Northwest Cancer Specialists Tutlatin — Portland, Oregon, United States
• University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2) — Pittsburgh, Pennsylvania, United States
• The Jones Clinic Dept .of The Jones Clinic (3) — Germantown, Tennessee, United States
• University of Arizona / Cancer Center AZ Onc Assoc — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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