Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer
The purpose of this pilot study is to see if taking anastrozole (Arimidex) for 10 days causes changes in breast cancer cells. Anastrozole (Arimidex) is a drug used in the treatment of a type of breast cancer that depends on estrogen to grow. This type of breast cancer is called estrogen receptor positive breast cancer. Anastrozole (Arimidex) works by blocking an enzyme in your body called aromatase. Aromatase is found in your muscles, fat, liver and in breast tumors. This enzyme is important for making estrogen in women who are no longer having menstrual periods. Anastrozole decreases levels of estrogen in the body. We are interested in seeing if taking anastrozole for 10 days will cause changes in breast cancer cells. We will study cell processes such as how they make new blood vessels, how quickly the cells multiply, and how soon they die. We will also study which genes in the breast cancer tissues are turned on or off by taking anastrozole for 10 days.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Analysis of Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer|
- To determine whether short term exposure to endocrine therapy (anastrozole) induces changes in gene expression in human invasive breast cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To evaluate the effects of anastrozole-mediated aromatase inhibition on surrogate biomarkers for cell proliferation, apoptosis, and angiogenesis. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
This is an exploratory study utilizing micro-array technology and immunohistochemistry to test the hypothesis that changes in gene expression occur as an early event in response to endocrine therapy and that these changes can be correlated with changes in surrogate biological markers.
anastrozole 1mg/day 11 days before their surgery and to take the last dose of the oral endocrine agent (anastrozole) on the day before their surgery.
Placebo Comparator: 2
no medication before surgery
No medication before surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588003
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Tari King, MD||Memorial Sloan-Kettering Cancer Center|