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A Phase III Study of Fulvestrant with or without Lapatinib (Tykerb®) for Postmenopausal Women with Hormone-Receptor-Positive Advanced Breast Cancer
[Protocol 07-122]
- Full Title :
- ENDOCRINE THERAPY WITH OR WITHOUT INHIBITION OF EGF AND HER2 GROWTH FACTOR RECEPTORS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III TRIAL OF FULVESTRANT WITH OR WITHOUT LAPATINIB (GW572016) FOR POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER (CALGB 40302)
- Purpose :
Lapatinib (Tykerb) is a drug that was approved in 2007 for treating advanced breast cancer that is positive for the HER2 protein. Fulvestrant (Faslodex®) is a standard form of hormonal therapy commonly used in breast cancer treatment. In this study, researchers want to determine if adding lapatinib to fulvestrant therapy is more effective than fulvestrant alone in postmenopausal women with advanced hormone receptor-positive breast cancer.
Patients will be randomly assigned to receive fulvestrant alone or fulvestrant with lapatinib.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage IV breast cancer or stage III disease that is not amenable to curative therapy. Patients' tumors must be hormone receptor-positive and express HER2.
- Patients must have had one or two prior regimens of hormonal therapy and must have demonstrated some sensitivity to hormonal therapy.
- Patients who have had prior chemotherapy must have completed treatment at least 2 weeks before entering the study. Patients may have had prior trastuzumab in the adjuvant setting (but not for metastatic disease) and must have completed treatment at least 3 weeks before entering the study.
- Patients may not have had prior treatment with fulvestrant or lapatinib or other EGFR inhibitors.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be postmenopausal women age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Diana Lake at 646-888-4562.
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