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Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer

NCT ID: NCT00588003

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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Breast ANASTROZOLE

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

anastrozole

Intervention Type 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.

2

no medication before surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

No medication before surgery

Interventions

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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.

Intervention Type DRUG

Placebo

No medication before surgery

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tari King, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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03-153

Identifier Type: -

Identifier Source: org_study_id