Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Nancy Lin, MD
Study ID
NCT00470704
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
  • Herceptin — DRUG

Study Details

In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.

Key Dates

Start date
May 14, 2007
Status verified
Dec 2024
Primary completion
Nov 30, 2013
Completion
Aug 20, 2024

Study Design

Enrollment
87 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1
    This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
  • Other: Cohort 2
    This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab

Primary Outcome Measure

Objective Response Rate [ Time Frame: 8 weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
University fo Alabama at BirminghamBirminghamAlabama35294-
University of ChicagoChicagoIllinois60452-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber at Faulkner HospitalBostonMassachusetts02130-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
University of North CarolinaChapel HillNorth Carolina27599-
Vanderbilt UniversityNashvilleTennessee37232-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University fo Alabama at Birmingham· Birmingham, ALUniversity of Chicago· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MADana-Farber at Faulkner Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MN

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