Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2004 |
| End Date: | November 2009 |
Analysis of 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.
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.
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.
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.
Inclusion Criteria:
- Postmenopausal patients, defined as one or more of the following 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.
- Clinically palpable or non-palpable T1c or greater, ER positive invasive breast
cancer diagnosed by outside core biopsy.
- Outside diagnosis of invasive breast cancer confirmed at MSKCC
- Palpable or non-palpable breast mass > 1cm highly suspicious for invasive breast
cancer based on mammographic, ultrasound and/or physical examination findings and
amenable to diagnostic core biopsy.
- Core biopsy diagnosis of ER positive invasive breast cancer performed at MSKCC
- Breast conserving surgery or mastectomy scheduled at MSKCC.
- Informed consent obtained.
Exclusion Criteria:
- Co-morbid conditions which would preclude use of aromatase inhibitors such as:
previous hypersensitivity, severe hepatic insufficiency (SGOT or SGPT three times the
upper limit of normal), severe renal insufficiency (creatinine clearance <10ml/min).
Prior radiation therapy to chest wall / breast.
- Neoadjuvant chemotherapy
- Hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months
- ER negative breast cancer
- History of active malignancy within the previous 5 years (except for nonmelanoma skin
cancer and breast cancer)
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