This phase II trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery (unresectable). Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive unresectable breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02760030.
PRIMARY OBJECTIVE:
I. To determine treatment failure–free survival (TFFS) rate at one year.
SECONDARY OBJECTIVES:
I. To determine 1- and 2-year progression free survival.
II. To determine safety and toxicity of this combination in this patient population.
III. To determine whether longitudinal changes in geriatric assessment measures correlate with tolerability of this regimen.
OUTLINE:
Patients receive fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, and day 1 of subsequent cycles. Patients also receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients may also receive anastrozole, letrozole, or exemestane PO QD on days 1-28 at the discretion of the treating physician. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo mammogram and ultrasound throughout the study.
After completion of study treatment, patients are followed up for 12 weeks and 2 years.
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorNicole O. Williams
