Breast CancerNCT00923377
Breast Stem Cells in Women at Average Risk and Increased Risk for Breast Cancer
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2007to 11 May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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....
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Cancer Prevention, High Risk, Breast Stem Cells, Mammographic Density, Breast Cancer Risk
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start23 Mar 2007
- Study completion11 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923377
- Sponsor's protocol ID
- 070123
- Other IDs
- 07-C-0123
- Status last verified
- 11 May 2010
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Smith GH, Chepko G. Mammary epithelial stem cells. Microsc Res Tech. 2001 Jan 15;52(2):190-203. doi: 10.1002/1097-0029(20010115)52:23.0.CO;2-O.
PubMed 11169867Dontu G, Abdallah WM, Foley JM, Jackson KW, Clarke MF, Kawamura MJ, Wicha MS. In vitro propagation and transcriptional profiling of human mammary stem/progenitor cells. Genes Dev. 2003 May 15;17(10):1253-70. doi: 10.1101/gad.1061803.
PubMed 12756227Kuperwasser C, Chavarria T, Wu M, Magrane G, Gray JW, Carey L, Richardson A, Weinberg RA. Reconstruction of functionally normal and malignant human breast tissues in mice. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4966-71. doi: 10.1073/pnas.0401064101. Epub 2004 Mar 29.
PubMed 15051869
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Identify and Characterize Breast Stem Cells in Women at Average Risk and Increased Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT00923377
- Acronym / sponsor ID
- 070123
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Cancer Prevention, High Risk, Breast Stem Cells, Mammographic Density, Breast Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Mar 2007
- Study completion
- 11 May 2010
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11169867Smith GH, Chepko G. Mammary epithelial stem cells. Microsc Res Tech. 2001 Jan 15;52(2):190-203. doi: 10.1002/1097-0029(20010115)52:23.0.CO;2-O.
- Background: PubMed 12756227Dontu G, Abdallah WM, Foley JM, Jackson KW, Clarke MF, Kawamura MJ, Wicha MS. In vitro propagation and transcriptional profiling of human mammary stem/progenitor cells. Genes Dev. 2003 May 15;17(10):1253-70. doi: 10.1101/gad.1061803.
- Background: PubMed 15051869Kuperwasser C, Chavarria T, Wu M, Magrane G, Gray JW, Carey L, Richardson A, Weinberg RA. Reconstruction of functionally normal and malignant human breast tissues in mice. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4966-71. doi: 10.1073/pnas.0401064101. Epub 2004 Mar 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.