Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 2 | Placebo Comparator | no medication before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anastrozole | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether short term exposure to endocrine therapy (anastrozole) induces changes in gene expression in human invasive breast cancer. | conclusion of study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of anastrozole-mediated aromatase inhibition on surrogate biomarkers for cell proliferation, apoptosis, and angiogenesis. | conclusion of study |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tari King, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | No medication before surgery |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |