Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer (EXTENT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer|
- Time to Disease Progression in Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]Time from the first day of treatment to date of progression in weeks
- Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine the Safety and Tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Exemestane plus Sutent
All patients enrolled on the study will receive treatment as follows:
Exemestane 25 mg by mouth every day.
Other Name: AromasinDrug: Sutent
Sunitinib 37.5 mg by mouth every day.
Other Name: (Sunitinib)
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:
- Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS).
- Determine the safety and tolerability of the combination regimen.
- Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and circulating endothelial cells (CECs), and explore associations with treatment response and resistance.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905021
|United States, Texas|
|Baylor College of Medicine, Lester and Sue Smith Breast Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mothaffar Rimiawi, MD||Baylor College of Medicine|