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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01007942
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • everolimus — DRUG
    Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
  • Placebo — DRUG
    Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
  • vinorelbine — DRUG
    intravenous vinorelbine (25 mg/m2 weekly)
  • trastuzumab — DRUG
    intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Study Details

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 Dates

Start date
Oct 31, 2009
Status verified
Feb 2017
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
569 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus + vinorelbine + trastuzumab
    Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
  • Placebo Comparator: placebo + vinorelbine + trastuzumab
    Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only

Primary Outcome Measure

Progressive-free Survival (PFS) Per Investigator Assessment [ Time Frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months ]

Locations (43)

FacilityCityStateZIPSite coordinators
University of Arizona / Cancer Center AZ Onc AssocTucsonArizona85724-
University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)TucsonArizona85724-
University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores CancerLa JollaCalifornia92093-0658-
Rocky Mountain Cancer Centers RMCCGreenwood VillageColorado--
Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)Washington D.C.District of Columbia20007-2197-
Comprehensive Cancer Center - Boca Raton Deerfield BeachBoca RatonFlorida33248-
Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtrBoca RatonFlorida33248-
Florida Cancer Specialists DeptofFloridaCancerSpecialistsFort MyersFlorida33916-
Memorial Hospital Memorial Cancer InstituteHollywoodFlorida33021-
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)OrlandoFlorida32806-
Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)AtlantaGeorgia30322-
North Shore University Health System NSUEvanstonIllinois60201-
Kansas City Cancer Center KCCC- South (2)Overland ParkKansas66210-
Maryland Oncology HematologyOwning MillsMaryland21117,-
Park Nicollet Institute Dept. of Park NicolletSaint Louis ParkMinnesota55416-
St. Louis University Cancer Center SLU Cancer CenterSt LouisMissouri63110-
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)OmahaNebraska68198-
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)Las VegasNevada89109-
Nevada Cancer Institute Dept. of Nevada Cancer (3)Las VegasNevada89135-
Overlook Hospital - Carol G Simon Cancer Center Carol G SimonSummitNew Jersey07901-
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)Lake SuccessNew York11042-
Duke University Medical Center Dept. of DUMC (2)DurhamNorth Carolina27710-
Northwest Cancer Specialists TutlatinPortlandOregon97210-
University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2)PittsburghPennsylvania15232-
The Jones Clinic Dept .of The Jones Clinic (3)GermantownTennessee38138-
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6)NashvilleTennessee37203-
Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2)DallasTexas75230-
Texas Oncology MidtownDallasTexas75251-
Texas Oncology Presbyterian Hospital (2)DallasTexas75246-
Texas Oncology Texas Onc - AmarilloDallasTexas75246-
Texas Oncology Texas Oncology - SammonsDallasTexas75246-
University of Texas Southwestern Medical Center University of TX SW Med Ctr(2)DallasTexas75390-8852-
Baylor College of Medicine BaylorHoustonTexas77030-
University of Texas/MD Anderson Cancer Center SC-5HoustonTexas77030-4009-
Longview Cancer Center Longview Cancer Center (2)LongviewTexas75601-
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)San AntonioTexas78229-
South Texas Oncology and Hematology, PA South Texas Oncology (2)San AntonioTexas78258-
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)TylerTexas75702-
Utah Cancer Specialists Utah Cancer (2)Salt Lake CityUtah84106-
Virginia Cancer Specialists Fairfax No.VA (2)FairfaxVirginia22031-
Virginia Oncology Associates Dept. of VOA (2)NorfolkVirginia23502-
Swedish Cancer Institute Swedish Cancer InstituteSeattleWashington98104-
Green Bay Oncology Green Bay OncologyGreen BayWisconsin54301-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Arizona / Cancer Center AZ Onc Assoc· Tucson, AZUniversity of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)· Tucson, AZUniversity of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer· La Jolla, CARocky Mountain Cancer Centers RMCC· Greenwood Village, COGeorgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)· Washington D.C., DCComprehensive Cancer Center - Boca Raton Deerfield Beach· Boca Raton, FL

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