Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer (EXTENT)
|ClinicalTrials.gov Identifier: NCT00905021|
Recruitment Status : Terminated (Sponsor withdrew support)
First Posted : May 20, 2009
Results First Posted : May 28, 2012
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Exemestane Drug: Sutent||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2012|
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)
- 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 ]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 ]
- Determine the Safety and Tolerability [ Time Frame: 5 years ]
- Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|