Protocol Number: 04-C-0199

Title:

Procurement of Normal Breast Tissue and Metastatic Breast Cancer Tissue for Molecular Profiling

Number:

04-C-0199

Summary:

This study will collect, analyze, and compare genes and proteins in normal breast tissue with those in various tissues from women with breast cancer to look for changes that are unique to breast cancer cells. Information about these differences may lead to more effective breast cancer treatments with fewer side effects. The study has the following objectives:

-To define the molecular (genetic and protein) profile of normal breast tissue from pre- and post-menopausal women of different ages and who have had varying numbers of children (or no children), and who are in different phases of the menstrual cycle

-To define the molecular profile of primary breast tumors and tumors that have metastasized (spread) beyond the primary site

-To characterize breast cancer stem cells and establish cell lines from the pleural fluid (fluid around the lungs) of women with metastatic breast cancer. (A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen.)

The following women may be eligible for this study:

-Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue (e.g., breast reduction surgery)

-Women 18 years of age or older who are undergoing a biopsy or other surgical procedure to sample or remove a known or suspected primary or metastatic breast tumor

-Women 18 years of age or older who are undergoing pleurocentesis, a procedure to remove fluid from around the lung that is suspected or known to be caused by spread of breast cancer

Participants undergo the required procedure (e.g., surgery, biopsy, or pleurocentesis) and provide information that may include the following:

-Age, race/ethnicity

-Age at first menstrual period (menarche)

-Age at first pregnancy and age when the first child was born

-Age at menopause

-Information about primary breast cancer

-Family history of breast cancer

-Information on previous breast biopsies, if any, and hormones taken (birth control pills or hormone replacement therapy), if any

-Copy of pathology report from procedure (surgery, biopsy, or pleurocentesis)

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

INCLUSION CRITERIA:

1. Subjects of any age who are undergoing cosmetic breast surgery that entails resection of breast tissue (e.g., reduction mammoplasty) for any reason.

2. Women (18 years of age or older) with known or suspected breast cancer who are undergoing a diagnostic biopsy or resection of a primary breast lesions or a site of metastatic tumor.

3. Women (18 years of age or older) with breast cancer who are undergoing a pleurocentesis for removal of fluid from a known or suspected malignant pleural effusion.

4. All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding that the specimens collected and demographic information provided is only for research purposes. Written assent will be obtained from pediatric patients (less than 18 years of age).

EXCLUSION CRITERIA:

1. Subjects who are undergoing cosmetic breast procedures such as reduction mammoplasty (collection of normal breast tissue) are excluded if they have a prior history of breast cancer.

Special Instructions:

Currently Not Provided

Keywords:

Gene Expression

Microarray

Stem Cell

Proteomics

Metastases

Recruitment Keyword(s):

Breast Tissue

Normal Breast Tissue

Breast Cancer

Condition(s):

Breast Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Russo J, Rivera R, Russo IH. Influence of age and parity on the development of the human breast. Breast Cancer Res Treat. 1992;23(3):211-8.

Russo J, Ao X, Grill C, Russo IH. Pattern of distribution of cells positive for estrogen receptor alpha and progesterone receptor in relation to proliferating cells in the mammary gland. Breast Cancer Res Treat. 1999 Feb;53(3):217-27.

Hovey RC, Trott JF, Vonderhaar BK. Establishing a framework for the functional mammary gland: from endocrinology to morphology. J Mammary Gland Biol Neoplasia. 2002 Jan;7(1):17-38. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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