EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer
The study design is a phase II design. Eligible patients will undergo staging work up and
start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations
will be performed every 4 weeks and staging work up will be repeated every 12 weeks.
The primary objective of the study is to assess progression free survival (PFS) of treatment
with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive
(ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer
subjects who have progressed on prior hormonal treatment.
In addition we want to:
1. Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and
overall survival (OS).
2. Determine the safety and tolerability of the combination regimen.
3. Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and
circulating endothelial cells (CECs), and explore associations with treatment response
1. Blood samples will be drawn for enumeration and profiling of circulating tumor cells and
circulating endothelial cells at study entry (prior to starting study medications), four
weeks after starting study medications, twelve weeks after starting study medications and at
disease progression. These samples will be strongly encouraged but the patients may decline
any or all of them without impacting their eligibility or continuation on the study.
2. If the patient participating on the study has an easily accessible breast mass or
metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core
needle or punch biopsy will be obtained at study entry (prior to starting study
medications), four weeks after starting study medications, and at disease progression. These
biopsies will be strongly encouraged but the patients may decline any or all of them without
impacting their eligibility or continuation on the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Disease Progression in Weeks
Time from the first day of treatment to date of progression in weeks
Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance
Mothaffar Rimiawi, MD
Baylor College of Medicine
United States: Institutional Review Board
H 24786 / EXTENT
|Baylor College of Medicine, Lester and Sue Smith Breast Center||Houston, Texas 77030|