Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Puma Biotechnology, Inc.
Study ID
NCT00777101
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Neratinib — DRUG
    Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
  • Lapatinib — DRUG
    Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
  • Capecitabine — DRUG
    Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Study Details

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Key Dates

Start date
Feb 4, 2009
Status verified
Jul 2018
Primary completion
Mar 31, 2011
Completion
Jun 3, 2018

Study Design

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

Arms

  • Experimental: Neratinib
  • Active Comparator: Lapatinib plus Capecitabine

Primary Outcome Measure

Progression Free Survival [ Time Frame: From randomization date to progression or death, assessed up to 69 months ]

Locations (44)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates HOPETucsonArizona85704-7891-
Southwest Cancer CareMurrietaCalifornia92562-
UC Irvine Medical CenterOrangeCalifornia92868-3298-
Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical CenterPalm SpringsCalifornia92262-
Redwood Regional Medical Group, Inc.Santa RosaCalifornia95403-
Rocky Mountain Cancer CenterDenverColorado80220-
Hematology Oncology Associates, P.C.StamfordConnecticut06902-
Palm Beach Institute of Hematology & OncologyBoynton BeachFlorida33435-
Robert R. Carroll, MD, PAGainesvilleFlorida32605-
University of FloridaJacksonvilleFlorida32209-
Hematology Oncology AssociatesLoxahatchee GrovesFlorida33470-
Mercy Research InstituteMiamiFlorida33133-
Cancer Centers of FloridaOrlandoFlorida32806-
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952-
Cancer Care Specialists Of Central IllinoisDecaturIllinois62526-
Oncology Specialists, SCPark RidgeIllinois60068-
Midwestern Regional Medical CenterZionIllinois60099-
Central Indiana Cancer CentersFishersIndiana46037-
Hematology Oncology of IndianaIndianapolisIndiana46260-2082-
Floyd Memorial Cancer Center of IndianaNew AlbanyIndiana47150-
Ashland-Bellefonte Cancer CenterAshlandKentucky41101-
Owsley Brown Frazier Cancer Center (OBFCC)LouisvilleKentucky40245-
Purchase Cancer GroupPaducahKentucky42001-
Missouri Cancer AssociatesColumbiaMissouri65201-
Capitol Comprehensive Cancer Care ClinicJefferson CityMissouri65109-
Arena Oncology Associates, PCLake SuccessNew York11042-
Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast CenterNew YorkNew York10065-
New York Oncology Hematolgy, PCTroyNew York12180-
Oncology Partners NetworkCincinnatiOhio45247-
MetroHealth Medical Center, Cancer Care CenterClevelandOhio44109-
University of Oklahoma Health Sciences Center Dept. of Hematology OncologyOklahoma CityOklahoma73104-
Northwest Cancer Specialists, PCPortlandOregon97213-
Lancaster Cancer CenterLancasterPennsylvania17605-
Allegheny General Hospital Allegheny Cancer CenterPittsburghPennsylvania15212-
Cookeville Regional Medical CenterCookevilleTennessee38501-
Center for Biomedical ResearchKnoxvilleTennessee37909-
Thompson Cancer Survival Center Thompson Oncology GroupKnoxvilleTennessee37916-
University of Tennessee Cancer InstituteMemphisTennessee38104-
Texas Oncology, P.A.AustinTexas78731-4214-
El Paso Cancer Treatment Center - WestEl PasoTexas79902-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
HOPE OncologyRichardsonTexas75080-
Cancer Care Network of South Texas-HOASTSan AntonioTexas78229-
East Texas Medical Center Cancer Institute, Tyler Hematology OncologyTylerTexas75701-2043-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Arizona Oncology Associates HOPE· Tucson, AZSouthwest Cancer Care· Murrieta, CAUC Irvine Medical Center· Orange, CAAptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center· Palm Springs, CARedwood Regional Medical Group, Inc.· Santa Rosa, CARocky Mountain Cancer Center· Denver, CO

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