Breast Stem Cells in Women at Average Risk and Increased Risk for Breast Cancer

June 30, 2017 updated by: National Cancer Institute (NCI)

Pilot Trial to Identify and Characterize Breast Stem Cells in Women at Average Risk and Increased Risk for Breast Cancer

Background:

  • Research suggests that breast cancers may arise from a population of stem cells in the normal mammary gland that produce clones of cancer cells.
  • Researchers are now trying to determine what events may initiate the formation of cancer cells.

Objectives:

  • To look for and describe breast stem cells from normal breast tissue from women who do not have breast cancer.
  • To compare the breast stem cells between women at increased risk for breast cancer and women at average risk for breast cancer.
  • To show a relationship between the number and type of breast stem cells with the density (appearance) of the mammogram (breast x-ray).
  • To make cell cultures (grow cells under controlled conditions) from the breast stem cells.

Eligibility:

-Women 18 years of age and older who are at average or increased risk for breast cancer.

Design:

Participants complete a health history questionnaire, family history questionnaire and risk assessment questionnaire.

  • Participants have a mammogram and breast biopsy (surgical removal of a sample of breast tissue).
  • Women who can become pregnant have a urine pregnancy test....

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Emerging models of breast cancer suggest that breast cancers arise from a population of stem cells that are present in the normal mammary gland. The stem cell produces a clone of cancer cells.

Researchers are now attempting to isolate and characterize breast stem cells and determine what events may initiate the tumorigenic process.

Objectives:

To identify and characterize breast stem cells from normal breast tissue from women who are free of breast cancer.

To compare characteristics of breast stem cells between women at increased risk for breast cancer and women at average risk for breast cancer.

To correlate breast stem cell number or characteristics with mammographic density.

To establish cell cultures of breast stem cells from women at increased risk for breast cancer and women at average risk for breast cancer.

Eligibility:

Women who are at average or increased risk for breast cancer and over age 18 will be eligible.

Design:

This is a pilot tissue acquisition trial. Breast biopsies will be obtained from all subjects and breast cancer risk demographics will be collected at one time point. We aim to enroll 20 average risk and 20 increased risk women.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA:

Women age 18 and older.

No abnormal findings in the breast by physical examination.

Average Risk: must meet all criteria below.

  • Gail model index of less than 1.7% over next 5 years.
  • Claus model lifetime risk less than 10%.
  • BRCAPro and Couch model less than 10% of being a BRCA mutation carrier OR tested negative for documented deleterious BRCA1/2 mutation in family.

Increased risk for invasive breast cancer by one of the following:

  • Gail Model risk of greater than 1.7% over 5 years from study entry.
  • Claus model lifetime risk to age 79 greater than or equal to 10%.
  • History of high risk pathologic lesion: lobular carcinoma in situ, atypical hyperplasia, DCIS (ductal carcinoma in situ).
  • Deleterious mutations in BRCA1/2, PTEN or P53.
  • Greater than or equal to 10% chance of carrying BRCA1/2 gene mutation as assessed by BRCAPro and Couch model (22, 23). If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.
  • History of unilateral breast cancer either invasive or in situ, and a normal contralateral breast by physical examination.

Willing to stop NSAIDS for 3 days prior to biopsy and aspirin 7 days prior to biopsy.

If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 3 months preceding enrollment.

Identification of dense area of breast tissue suitable for biopsy identified on mammogram by the radiologist.

EXCLUSION CRITERIA:

Current use of hormonal therapies (e.g. tamoxifen, aromatase inhibitors, hormone replacement therapy, oral contraceptive pills, topical or vaginal hormone medications are allowed.)

Chemotherapy and radiation within 3 months prior to breast biopsy procedure.

Breastfeeding within 3 months.

Pregnancy (determined by urine dipstick).

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

Bleeding disorder.

Warfarin, low molecular weight heparin, or heparin use.

History of bilateral breast radiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 23, 2007

Study Completion

May 11, 2010

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

May 11, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070123
  • 07-C-0123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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