Ph III Trial to Compare Safety and Efficacy of Lapatinib Plus Trastuzumab Plus Aromatase Inhibitor (AI) vs. Trastuzumab Plus AI vs. Lapatinib Plus AI as 1st Line in Postmenopausal Subjects With Hormone Receptor+ HER2+ MBC Who Received Trastuzumab and Endocrine Therapy in Neo- and/or Adjuvant Setting
This is a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus
trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an
AI to evaluate the efficacy and safety of these regimens as first-line therapy in
postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic
breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant
and/or adjuvant setting. Eligible subjects will be postmenopausal; have tumors that are ER
and/or PgR positive and HER2-positive; have newly diagnosed Stage IV metastatic breast
cancer; and have not received systemic or local treatment for MBC. The primary objective is
to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.)
trastuzumab/AI combination for overall survival. The secondary objectives are to evaluate
overall survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs.
lapatinib/AI, progression free survival, overall response rate, clinical benefit rate, the
safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an
AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to
baseline.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination
approximately 6 years
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
114299
NCT01160211
May 2011
December 2017
Name | Location |
---|---|
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Park Ridge, Illinois 60068 |
GSK Investigational Site | Bettendorf, Iowa 52722 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Omaha, Nebraska 68131 |
GSK Investigational Site | Seattle, Washington 98133 |