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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588003
First Posted: January 8, 2008
Last Update Posted: December 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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 Phase
Breast Cancer Drug: anastrozole Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Analysis of Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate the effects of anastrozole-mediated aromatase inhibition on surrogate biomarkers for cell proliferation, apoptosis, and angiogenesis. [ Time Frame: conclusion of study ]

Enrollment: 45
Study Start Date: March 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Placebo Comparator: 2
no medication before surgery
Other: Placebo
No medication before surgery

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588003


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Tari King, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588003     History of Changes
Other Study ID Numbers: 03-153
First Submitted: December 22, 2007
First Posted: January 8, 2008
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast
ANASTROZOLE

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs