Protocol Number: 02-C-0144

Title:

Establishment of Normal High Risk Breast Epithelial Cell Cultures, and A High Risk Cell Line and Tissue Repository from Breast Tissue from Women at High Risk of Breast Cancer

Number:

02-C-0144

Summary:

This protocol will establish cell lines of breast tissue and a breast tissue repository to study changes in breast cells that may cause them to become cancerous. A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen. A repository is a special facility in which the tissue samples can be preserved and stored for many years. With the establishment of this repository, tissues and cells lines from all types or categories of breast cancer risk can be compared with normal tissue, allowing researchers to better determine the characteristics of cancer risk for different risk categories.

Women between 20 and 80 years of age may be eligible for this study. It will include up to 100 women at risk of developing breast cancer and about 10 women with no known risk of breast cancer. Women who have had radiation therapy to the chest area for lymphoma before age 30 are also eligible. All candidates will be screened with a history, physical examination, blood tests, pregnancy test, and a mammogram, if one has not been done within 6 months of entering the study. Women who have or have had breast cancer will be evaluated for previous therapy. Women who have not had breast cancer and who have no strong family history of the disease will have their risk level determined using a computer program for the Gail model risk of breast cancer.

A small breast tissue sample (about 1.5 inches) will be collected from participants at the time of breast surgery, for example, during mastectomy or breast reconstruction in patients, or during elective breast reduction in women without cancer. A blood sample (about 3 tablespoons) will be drawn for study along with the breast tissue. The samples will be stored with a coded identifier, such as a number, and will be separate from any information linking the tissue to the donor.

The tissues will be studied for gene and protein characteristics, metabolism of certain breast cells, and for testing and developing drugs to prevent breast cancer.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Children

Male

Eligibility Criteria:

INCLUSION CRITERIA:

To be eligible, women must have one of the following:

Women 20-80 years of age who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family. An Individual with a family history of verified breast and/or ovarian cancer is defined as including one of the following: 1) at least four cases of breast cancer. 2) Three cases of breast cancer and at least one case of ovarian cancer (two cases of ovarian cancer of which have to be first degree relatives). 3) Two cases of ovarian cancer in first degree relatives. High risk families may also include those with at least 4 cases of early onset (age less than 60) breast cancer or ovarian cancer (diagnosis at any age), or any family known to segregate a mutation in BRCA1 or another predisposing gene (i.e. BRCA2).

Women with a history of ipsilateral breast cancer, either invasive or in situ, and a normal contralateral breast by mammography (within the past 12 months) and a normal physical examination of the contralateral breast and adjacent lymph node bearing areas, or be undergoing prophylactic mastectomy.

Women without breast cancer but with a Gail model estimate of 5-year risk of breast cancer of 1.67 percent or higher.

Women with bilateral breast cancer (invasive or in situ) who have not received whole breast irradiation to both breasts.

Women with a previous history of mediastinal irradiation for lymphoma before the age of 30 and who are now greater than or equal to 5 years since completing radiation therapy.

Normal women not at increased risk of breast cancer (Gail model Index of less than 1.50%) and without abnormal findings in the breast by physical examination and mammography to serve as normal control tissue.

Women with a mutation in a breast cancer susceptibility gene, but whose family history is not known.

Women with ipselateral breast cancer who are undergoing a mastectomy for that breast cancer.

Absence of significant cardiac, hepatic or renal disease, which, in the opinion of the PI, is likely to cause metabolic changes in the breast tissues.

EXCLUSION CRITERIA:

Chemotherapy within 3 weeks prior to breast biopsy procedure.

Pregnancy, (applicable to patients participating at NIH only).

White blood count less than 2000, platelet count less than 50,000, (applicable to patients participating at NIH only).

Concurrent infection.

A history of bilateral whole breast radiation therapy.

A suspicious unbiopsied lesion by physical examination or mammography of the breast(s) which is being studied.

Special Instructions: Currently Not Provided

Keywords:

Surgery

Tissue Sample

Gene Expression Profiling

Tissue Array Gene Expression

Comparative Genomic Hybridization

Recruitment Keywords:

Breast Cancer

Breast Cancer Risk

Breast

Conditions:

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

Henderson IC Risk factors for breast cancer developmentCancer 1993 Mar 15;71(6 Suppl):2127-40 Review No abstract available

Widschwendter M;Loss of retinoic acid receptor beta expression in breast cancer and morphologically normal adjacent tissue but not in the normal breast tissue distant from the cancer,Cancer Res 1997 Oct 1;57(19):4158-61

Woodcock DM, Linsenmeyer ME, Doherty JP, Warren WDDNA methylation in the promoter region of the p16 (CDKN2/MTS-1/INK4A) gene in human breast tumours Br J Cancer 1999 Jan;79(2):251-6

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