Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

Launched by BAYLOR BREAST CARE CENTER · Oct 21, 2009

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination treatment for women with advanced breast cancer. The treatment includes two targeted therapies called lapatinib and trastuzumab, which work together to attack cancer cells. Researchers want to understand how effective this combination is, especially for women whose tumors are driven by certain proteins (HER2) that promote cancer growth. The goal is to see if this treatment can help shrink tumors and prevent them from coming back.

To participate in the trial, women must be at least 18 years old and have a specific type of breast cancer that is confirmed to be HER2 positive. They should not have any other active cancers, serious health issues, or have undergone any breast cancer treatments in the last five years. Participants will receive the study drugs and will be monitored closely to assess how well the treatment is working and if there are any side effects. Overall, this trial aims to find better ways to treat breast cancer and improve outcomes for patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. All patients must be female and at least 18 years of age.
• • 2. Signed informed consent.
• • 3. 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.)
• • 4. 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.
• • 5. Negative serum pregnancy test (HCG) within 7 days of starting study drug, if of child-bearing potential.
• • 6. Kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.
• • 7. Performance status (WHO/ECOG scale) 0-1 and life expectancy \>6 months.
• • 8. No evidence of brain or leptomeningeal disease, or any other Stage IV disease.
• • 9. 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 Criteria:
• • 1. Patients with bilateral breast cancer.
• • 2. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• • 3. Severe underlying chronic illness or disease.
• • 4. Cardiomyopathy or baseline LVEF less than 50%.
• • 5. Other investigational drugs while on study.
• • 6. Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
• • 7. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
• • 8. Taking any lapatinib prohibited medication(s)
• • 9. Inability or unwillingness to comply with, or follow study procedures.
• • 10. 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.
• • 11. Patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.
• • 12. Patients with known active, infectious Hepatitis B, Hepatitis C, or HIV.