Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Gary Schwartz
Study ID
NCT00225758
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    1500 mg po daily for 26 weeks or longer

Study Details

Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response to these agents is unpredictable, however, and approximately one-third of patients with metastatic breast cancer with receptors for estrogen or progesterone have no benefit from hormonal therapy. Nearly all patients with metastatic breast cancer will eventually become resistant to hormonal therapy despite the fact that the hormone receptors are still present. Some cells make a different class of growth factor receptor called the Epidermal Growth Factor Receptor. There is a growing body of experimental evidence showing that breast cancer cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and have a poorer prognosis. Several investigators have found that the Epidermal Growth Factor Receptor can activate the estrogen receptor, even in the presence of estrogen-blocking drugs. Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor signaling and estrogen-receptor signaling. Lapatinib is a small molecule which can inhibit two different forms of the Epidermal Growth Factor Receptor. It has been studied in people with a number of different cancers, including breast cancer, and a safe dose and its common side effects have been defined. Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway used by breast cancers in our patients with hormone-resistant tumors. Drugs like lapatinib which block several forms of the Epidermal Growth Factor Receptor would best be able to reverse resistance to hormonal agents.

Key Dates

Start date
Jan 31, 2006
Status verified
Jul 2018
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

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

Arms

  • Experimental: 1
    Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.

Primary Outcome Measure

Determine the Response Rate and Progression Free Survival of Hormone Therapy-resistant Patients With Metastatic Breast Cancer Treated With the Same Continued Hormonal Agent With the Addition of Lapatinib. [ Time Frame: 26 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
Norris Cotton Cancer CenterLebanonNew Hampshire03756-
North Shore University HospitalLake SuccessNew York11042-

Find similar trials in Aurora, CO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Colorado Cancer Center· Aurora, CONorris Cotton Cancer Center· Lebanon, NHNorth Shore University Hospital· Lake Success, NY

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