Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus
fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progressed
after first line hormonal therapy.
- Total number of subjects planned for the trial is 130 subjects, that is, approximately
65 subjects in each arm.
- Subjects will be randomized to receive fulvestrant/erlotinib (arm A) or
fulvestrant/placebo (arm B) and stratified based on accrual center.
- The study is a parallel-arm double-blind study, with fulvestrant + placebo on the
monotherapy arm, and fulvestrant + erlotinib on the combination arm.
- The primary variable outcome is time to progression.
- Subjects whose metastatic disease was diagnosed more than 12 months after completing
adjuvant hormonal therapy are eligible to this study if their breast cancer is
hormone-receptor-positive and after disease progression on first line hormonal therapy
in the metastatic setting. Subjects may have received no more than one line of
chemotherapy. While receiving one line of hormonal therapy in the metastatic setting is
a requirement, receiving chemotherapy is not, and one line of chemotherapy in the
metastatic setting would not exclude these subjects from the trial. Subjects who had a
recurrence while on adjuvant hormonal treatment or within 12 months of completion of
the adjuvant hormonal treatment are also eligible without the need to receive first
line hormonal therapy in the metastatic setting.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To obtain estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib; estimates of the magnitude and variability of the efficacy of fulvestrant. This measure will be obtained by time to progression.
Issam Makhoul, MD
University of Arkansas
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Highlands Oncology Group||Springdale, Arkansas 72764|
|Emory University||Atlanta, Georgia 30322|
|Hackensack University||Hackensack, New Jersey 07601|
|NEA Clinic||Jonesboro, Arkansas 72401|
|St. Luke's Cancer Institute||Kansas City, Missouri 64111|