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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588003 |
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.
Condition | Intervention |
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Breast Cancer |
Drug: anastrozole Other: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Bio-availability Study |
Official Title: | Analysis of Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: anastrozole
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.
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2: Placebo Comparator
no medication before surgery
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Other: Placebo
No medication before surgery
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Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented history of bilateral oophorectomy, Aged 60 years or more,
Aged 45-59 years and satisfying one or more of the following criteria:
Amenorrhea for at least 12 months and intact uterus Amenorrhea for less than 12 months and follicle stimulating hormone (FSH) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past.
Exclusion Criteria:
Prior radiation therapy to chest wall / breast.
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 |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Tari King, MD ) |
Study ID Numbers: | 03-153 |
Study First Received: | December 22, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00588003 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast ANASTROZOLE |
Anastrozole Antineoplastic Agents, Hormonal Skin Diseases |
Breast Neoplasms Aromatase Inhibitors Breast Diseases |
Anastrozole Skin Diseases Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Breast Diseases |