Lapatinib and Trastuzumab With or Without Endocrine Therapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Baylor Breast Care Center
Study ID
NCT00548184
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    Monoclonal Antibody
  • Trastuzumab — DRUG
    Monoclonal Antibody
  • Endocrine — DRUG
    Hormonal Therapy

Study Details

We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors. The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.

Key Dates

Start date
May 31, 2008
Status verified
Oct 2019
Primary completion
Jan 31, 2011
Completion
Jan 31, 2014

Study Design

Enrollment
65 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Group Assignment
    Lapatinib Trastuzumab Endocrine

Primary Outcome Measure

Pathologic Assessment After Study Treatment [ Time Frame: 12 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
UAB Cancer CenterBirminghamAlabama35294-
The University of ChicagoChicagoIllinois60637-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bunting-Blaustein Cancer ResearchBaltimoreMaryland21231-1000-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6868-
Baylor College of Medicine, Lester and Sue Smith Breast CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UAB Cancer Center· Birmingham, ALThe University of Chicago· Chicago, ILSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bunting-Blaustein Cancer Research· Baltimore, MDMayo Clinic Cancer Center· Rochester, MNVanderbilt-Ingram Cancer Center· Nashville, TNBaylor College of Medicine, Lester and Sue Smith Breast Center· Houston, TX

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