Status:
ACTIVE_NOT_RECRUITING
Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy
Lead Sponsor:
Baylor Breast Care Center
Collaborating Sponsors:
Translational Breast Cancer Research Consortium
GlaxoSmithKline
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Breast cancer is the most common malignancy in the U.S. Targeted therapies such as tamoxifen have been revolutionary in reducing tumor recurrences and mortality in early breast cancer. Using this succ...
Detailed Description
Breast cancer cells have certain characteristics or traits--these traits are called biomarkers. There are three biomarkers that help doctors decide which treatment to give any given patient. These bio...
Eligibility Criteria
Inclusion
- All patients must be female and at least 18 years of age.
- Signed informed consent.
- Locally advanced breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size \>3 cm, or \>2 cm with clinical evidence of axillary nodal involvement\*. (If tumors are less than 3 cm, we will use the radiologically measured tumor size to determine if the tumor meets the minimal size requirements.)
- Patients must have histologically confirmed invasive mammary carcinoma that is HER2 overexpressing, defined as 3+ by immunohistochemistry, or a FISH/CEP ratio greater than 2.
- Negative serum pregnancy test (HCG) within 7 days of starting study drug, if of child-bearing potential.
- Kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.
- Performance status (WHO/ECOG scale) 0-1 and life expectancy \>6 months.
- No evidence of brain or leptomeningeal disease, or any other Stage IV disease.
- No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Exclusion
- Patients with bilateral breast cancer.
- Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
- Severe underlying chronic illness or disease.
- Cardiomyopathy or baseline LVEF less than 50%.
- Other investigational drugs while on study.
- Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
- Taking any lapatinib prohibited medication(s)
- Inability or unwillingness to comply with, or follow study procedures.
- Patients who have received any form of treatment for breast cancer within the past five years, including surgical resection, chemotherapy, endocrine therapy, or biologic therapy.
- Patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.
- Patients with known active, infectious Hepatitis B, Hepatitis C, or HIV.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00999804
Start Date
October 1 2011
End Date
January 1 2026
Last Update
March 12 2025
Active Locations (8)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
Johns Hopkins
Baltimore, Maryland, United States, 21231