Clinical Research Details
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.
Purpose:
Primary: To compare the effect, in terms of progression free survival, of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with ER and/or PgR positive advanced breast cancer.
Study Number:
201094091708
Number of Patients:
324
Elgibility:
Postmenopausal women with a histologic, pathologic, or cytologic diagnosis of primary or metastatic stage IV breast cancer or locally advanced breast cancer stage III not amendable to curative therapy may be eligible. Patient must not have active CNS metastasis. Tumors must be ER and/or PgR positive. HER2 status must be known and can be either positive or negative. There must be at least 1 measurable lesion or bone metastasis. Patient must have had prior therapy with a third-generation aromatase inhibitor in either the adjuvant or metastatic setting. Patient must have also had prior therapy with one or two endocrine treatments (not including ovarian suppression) in either the adjuvant or metastatic setting. Patient must have had at most 1 prior chemotherapy regimen for advanced breast cancer. Prior therapy with trastuzumab for stage IV breast cancer, in combination with up to one chemotherapy and/or endocrine therapy regimen is allowed. Patient must not have had prior therapy with fulvestrant or EGFR inhibitors. Patient must not be on concurrent endocrine treatment. Patient must have adequate general health with an ECOG PS 0-2. Tumors must be potentially sensitive to endocrine therapy. Patients may have initiated bisphosphonate treatment prior to study entry.
Treatment:
Participants in this study will be randomly assigned to one of two treatment groups: Participants in group one will receive fulvestrant on day one of each treatment cycle (28 days) as an injection in the buttock muscle. During the third week of the first treatment cycle only, you will be given an extra dose of fulvestrant. Those in this group will also take six lapatinib tablets by mouth once a day for each 28-day treatment cycle.Participants in group two will receive fulvestrant on day one of each treatment cycle (28 days) as an injection in the buttock muscle. During the third week of the first treatment cycle only, you will be given an extra dose of fulvestrant. Participants in this group will also take six placebo tablets (an inactive substance) by mouth once a day for each 28-day treatment cycle.
Principal Investigator:
Enrollment Phone:
(708) 327-3222