Breast CancerNCT00028340
High-Risk Breast Duct Epithelium
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States. The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2003to 16 Dec 2022
- 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 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pre- or postmenopausal women who have or have previously had invasive or noninvasive breast cancer of epithelial origin, or women without breast cancer but at an increased risk of breast cancer. Pre- or postmenopausal women who are not at an increased risk for breast cancer.
Who may be able to join
- Inclusion Criteria for Breast Cancer and High-Risk Patients:
- Age greater than or equal to 18 years and less than or equal to 74 years.
- Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.
- Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
- Women known to be BRCA1/2 or other hereditary genes mutation carriers.
- Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or LCISl
Show all 19Show fewer
- Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months.
- Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.
- Breast cancer may be invasive or noninvasive, and in the past or the present.
- The contralateral breast of women with breast cancer, or the normal breast of high-risk subjects, must be free of any suspicious areas by physical examination and mammogram, and without a history of invasive ductal or in situ ductal carcinoma. History of atypia or LCIS on a previous biopsy is acceptable.
- Women who are from a family with heritable breast cancer with a known deleterious BRCA1/2 or other hereditary genes mutation, who themselves have been tested and to not carry this mutation. These women are not at increased risk for breast cancer due to the familial mutation and are eligible to participate as normal volunteers.
- WBC greater than 2,500.
- Platelets greater than 50,000.
- Age greater than or equal to 18 years and less than or equal to 74 years.
- Women who are premenopausal or postmenopausal with a Gail model risk index less than 1.67 percent, and without a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
- Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.
- Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age by mammogram. There must be no history of atypical hyperplasia, invasive or in situ carcinoma.
- WBC greater than 2,500.
- Platelets greater than 50,000.
Who cannot join
- Contralateral breast prosthesis
- Pregnancy
- History of radiation therapy to the contralateral breast
- Lactating breasts
- Chemotherapy within the past 1 month
- Current antiestrogen therapy
Show all 25Show fewer
- Current hormonal replacement therapy or oral contraceptives
- Concurrent infection
- Previous contralateral major duct excision
- Bilateral breast prosthesis
- Pregnancy
- Lactating breasts
- Current antiestrogen therapy
- Current hormonal replacement therapy or oral contraceptives
- Concurrent infection
- Previous bilateral major duct excision
- History of therapeutic mediastinal radiation
- Bilateral breast prosthesis
- Pregnancy
- Lactating breasts
- Current antiestrogen therapy
- Current hormonal replacement therapy or oral contraceptives
- Concurrent infection
- Previous bilateral major duct excision
- History of therapeutic mediastinal radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Characterization of High-Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile
Background:
- Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States.
- The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood, however several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ.
- The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment.
Read more
Objective:
Primary objectives are:
- To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer.
- To characterize by breast duct endoscopy, high risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet.
- To determine what is the global gene expression pattern of high risk breast epithelial cells from the high risk breast, and does this differ from that of breast epithelial cells from female normal volunteersnot at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Eligibility:
Eligibility for high risk individuals will include:
- Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.
- Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
- Women known to be BRCA1/2 or other hereditary genes mutation carriers.
- Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.
- Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months.
- Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/ml, and a serum estradiol level of less than40 pg/ml to document postmenopausal status.
Eligibility for normal volunteers will include:
- Women who are premenopausal or postmenopausal with a Gail model risk index less than 1.67 percent, and without a cumulative lifetime risk greater than or equal to double the age- and racematched general population risk.
- Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of >40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.
- Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age by mammogram. There must be no history of atypical hyperplasia, invasive or in situ carcinoma.
Both groups must have acceptable white blood cell and platelet counts.
Design:
Breast ductal epithelial cells will be collected by breast ductal lavage from (a) the breast in women at increased risk for breast cancer, and (b) the breast of female normal volunteers who are not at increased risk for breast cancer.
Ductal epithelial cell specimens will be analyzed cytologically for the presence of hyperplasia, atypia, or in situ changes.
Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers with cytologic atypia on ductal lavage to determine ductal architectural changes associated with increased risk for breast cancer, and to provide correlation with cytologic atypia.
The gene expression profile of normal and high-risk ductal epithelial cells will be studied by cDNA-microarray to determine changes in gene expression associated with increased risk for breast cancer.
Additional molecular profiling experiments which will be performed as lavage cells are available include DNA whole exome sequencing, Comparative Genomic Hybridization (CGH), proteomic tissue lysate arrays, and identification of mammary stem cells.
A total of 104 high-risk subjects and 110 normal volunteers will be studied, divided approximately evenly between premenopausal and postmenopausal women....
Read the detailed description
Background:
Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States.
The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood: however, several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ.
The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment.
Objective:
Primary objectives:
To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer.
To characterize by breast duct endoscopy high-risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet.
To determine what is the global gene expression pattern of high-risk breast epithelial cells from the high-risk breast, and does this differ from that of breast epithelial cells from female normal volunteers not at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Eligibility:
Eligibility for high-risk individuals will include:
Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.
Women without breast cancer, but with a Gail Index > 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
Women known to be BRCA1/2 or other hereditary genes mutation carriers.
Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.
Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months.
Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/mL, and a serum estradiol level of < 40 pg/mL to document postmenopausal status.
Eligibility for normal volunteers will include:
Women who are premenopausal or postmenopausal with a Gail model risk index < 1.67 percent, and without a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/mL, and a serum estradiol level of < 40 pg/mL to document postmenopausal status.
Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age, by mammogram. There must be no history of atypical hyperplasia, invasive, or in situ carcinoma.
Both groups must have acceptable white blood cell and platelet counts.
Design:
Breast ductal epithelial cells will be collected by breast ductal lavage from (a) the breast in women at increased risk for breast cancer, and (b) the breast of female normal volunteers who are not at increased risk for breast cancer.
Ductal epithelial cell specimens will be analyzed cytologically for the presence of hyperplasia, atypia, or in situ changes.
Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers with cytologic atypia on ductal lavage to determine ductal architectural changes associated with increased risk for breast cancer, and to provide correlation with cytologic atypia.
The gene expression profile of normal and high-risk ductal epithelial cells will be studied by cDNA microarray to determine changes in gene expression associated with increased risk for breast cancer.
Additional molecular profiling experiments which will be performed as lavage cells are available include DNA whole exome sequencing, comparative genomic hybridization (CGH), proteomic tissue lysate arrays, and identification of mammary stem cells.
A total of 104 high-risk subjects and 110 normal volunteers will be studied, divided approximately evenly between premenopausal and postmenopausal women.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Natural History
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Breast Cancer and High-Risk Patients | Pre- or postmenopausal women who have or have previously had invasive or noninvasive breast cancer of epithelial origin, or women without breast cancer but at an increased risk of breast cancer. | |
| 2/Normal Volunteers | Pre- or postmenopausal women who are not at an increased risk for breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast.
Using specimens collected by breast ductal lavage, and determine if these cytologic findings are different from those of normal women not at increased risk for breast cancer.
Measured: 25 years
Determine the global gene expression pattern of high-risk breast epithelial cells from the high-risk breast.
Determine if gene expression pattern differs from that of breast epithelial cells from female normal volunteers not at increased risk for breast cancer. Gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Measured: 25 years
Characterize high-risk breast ductal epithelium and architecture.
Characterize by breast duct endoscopy, and correlate these findings with the cytologic findings.
Measured: 25 years
Secondary outcomes (4)
Examine ductal epithelial cell preparations for the presence of mammary stem cells.
From both women at high risk and from women not at high risk for breast cancer.
Measured: 25 years
Determine the pattern of protein expression for selected proteins in the high-risk epithelial cells.
Using proteomics tissue lysate arrays.
Measured: 25 years
Determine the gross genomic alterations present in high-risk breast epithelial cells.
Using comparative genomic hybridization.
Measured: 25 years
Determine the DNA mutational pattern of breast epithelium from women at high risk for breast cancer.
Using DNA whole exome sequencing.
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2001 (estimated)
- Study start20 Feb 2003
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David N Danforth, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028340
- Sponsor's protocol ID
- 020077
- Other IDs
- 02-C-0077
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2001
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Publications
Fisher B, Costantino J, Redmond C, Fisher E, Margolese R, Dimitrov N, Wolmark N, Wickerham DL, Deutsch M, Ore L, et al. Lumpectomy compared with lumpectomy and radiation therapy for the treatment of intraductal breast cancer. N Engl J Med. 1993 Jun 3;328(22):1581-6. doi: 10.1056/NEJM199306033282201.
PubMed 8292119Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
PubMed 10735013Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12;353(9169):1993-2000. doi: 10.1016/S0140-6736(99)05036-9.
PubMed 10376613Danforth DN, Filie AC, Warner AC, Wright GW, Sun Z, Ried T, McGowan CT, Prindiville SA. Characteristics of Breast Ducts in Normal-Risk and High-risk Women and Their Relationship to Ductal Cytologic Atypia. Cancer Prev Res (Phila). 2020 Dec;13(12):1027-1036. doi: 10.1158/1940-6207.CAPR-19-0305. Epub 2020 Aug 4.
PubMed 32753377
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of High-Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile
- ClinicalTrials.gov ID
- NCT00028340
- Acronym / sponsor ID
- 020077
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Feb 2003 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 24 Dec 2001 (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:
- Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States.
- The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood, however several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ.
- The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment.
Objective:
Primary objectives are:
- To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer.
- To characterize by breast duct endoscopy, high risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet.
- To determine what is the global gene expression pattern of high risk breast epithelial cells from the high risk breast, and does this differ from that of breast epithelial cells from female normal volunteersnot at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Eligibility:
Eligibility for high risk individuals will include:
- Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.
- Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
- Women known to be BRCA1/2 or other hereditary genes mutation carriers.
- Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.
- Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months.
- Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/ml, and a serum estradiol level of less than40 pg/ml to document postmenopausal status.
Eligibility for normal volunteers will include:
- Women who are premenopausal or postmenopausal with a Gail model risk index less than 1.67 percent, and without a cumulative lifetime risk greater than or equal to double the age- and racematched general population risk.
- Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of >40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.
- Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age by mammogram. There must be no history of atypical hyperplasia, invasive or in situ carcinoma.
Both groups must have acceptable white blood cell and platelet counts.
Design:
Breast ductal epithelial cells will be collected by breast ductal lavage from (a) the breast in women at increased risk for breast cancer, and (b) the breast of female normal volunteers who are not at increased risk for breast cancer.
Ductal epithelial cell specimens will be analyzed cytologically for the presence of hyperplasia, atypia, or in situ changes.
Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers with cytologic atypia on ductal lavage to determine ductal architectural changes associated with increased risk for breast cancer, and to provide correlation with cytologic atypia.
The gene expression profile of normal and high-risk ductal epithelial cells will be studied by cDNA-microarray to determine changes in gene expression associated with increased risk for breast cancer.
Additional molecular profiling experiments which will be performed as lavage cells are available include DNA whole exome sequencing, Comparative Genomic Hybridization (CGH), proteomic tissue lysate arrays, and identification of mammary stem cells.
A total of 104 high-risk subjects and 110 normal volunteers will be studied, divided approximately evenly between premenopausal and postmenopausal women....
Detailed description
Background:
Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States.
The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood: however, several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ.
The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment.
Objective:
Primary objectives:
To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer.
To characterize by breast duct endoscopy high-risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet.
To determine what is the global gene expression pattern of high-risk breast epithelial cells from the high-risk breast, and does this differ from that of breast epithelial cells from female normal volunteers not at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Eligibility:
Eligibility for high-risk individuals will include:
Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.
Women without breast cancer, but with a Gail Index > 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
Women known to be BRCA1/2 or other hereditary genes mutation carriers.
Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.
Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 12 months.
Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/mL, and a serum estradiol level of < 40 pg/mL to document postmenopausal status.
Eligibility for normal volunteers will include:
Women who are premenopausal or postmenopausal with a Gail model risk index < 1.67 percent, and without a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk.
Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of > 40 IU/mL, and a serum estradiol level of < 40 pg/mL to document postmenopausal status.
Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age, by mammogram. There must be no history of atypical hyperplasia, invasive, or in situ carcinoma.
Both groups must have acceptable white blood cell and platelet counts.
Design:
Breast ductal epithelial cells will be collected by breast ductal lavage from (a) the breast in women at increased risk for breast cancer, and (b) the breast of female normal volunteers who are not at increased risk for breast cancer.
Ductal epithelial cell specimens will be analyzed cytologically for the presence of hyperplasia, atypia, or in situ changes.
Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers with cytologic atypia on ductal lavage to determine ductal architectural changes associated with increased risk for breast cancer, and to provide correlation with cytologic atypia.
The gene expression profile of normal and high-risk ductal epithelial cells will be studied by cDNA microarray to determine changes in gene expression associated with increased risk for breast cancer.
Additional molecular profiling experiments which will be performed as lavage cells are available include DNA whole exome sequencing, comparative genomic hybridization (CGH), proteomic tissue lysate arrays, and identification of mammary stem cells.
A total of 104 high-risk subjects and 110 normal volunteers will be studied, divided approximately evenly between premenopausal and postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Breast Cancer and High-Risk Patients | – | –Pre- or postmenopausal women who have or have previously had invasive or noninvasive breast cancer of epithelial origin, or women without breast cancer but at an increased risk of breast cancer. |
| 2/Normal Volunteers | – | –Pre- or postmenopausal women who are not at an increased risk for breast cancer. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre- or postmenopausal women who have or have previously had invasive or noninvasive breast cancer of epithelial origin, or women without breast cancer but at an increased risk of breast cancer. Pre- or postmenopausal women who are not at an increased risk for breast cancer.
Key inclusion criteria (19 listed)
- Age greater than or equal to 18 years and less than or equal to 74 years.
- Age greater than or equal to 18 years and less than or equal to 74 years.
Key exclusion criteria (25 listed)
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
Determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast.
Time frame: 25 years
Using specimens collected by breast ductal lavage, and determine if these cytologic findings are different from those of normal women not at increased risk for breast cancer.
Determine the global gene expression pattern of high-risk breast epithelial cells from the high-risk breast.
Time frame: 25 years
Determine if gene expression pattern differs from that of breast epithelial cells from female normal volunteers not at increased risk for breast cancer. Gene expression profile will be determined by cDNA microarray and validated by RT-PCR.
Characterize high-risk breast ductal epithelium and architecture.
Time frame: 25 years
Characterize by breast duct endoscopy, and correlate these findings with the cytologic findings.
4 secondary outcomes
Examine ductal epithelial cell preparations for the presence of mammary stem cells.
Time frame: 25 years
Determine the pattern of protein expression for selected proteins in the high-risk epithelial cells.
Time frame: 25 years
Determine the gross genomic alterations present in high-risk breast epithelial cells.
Time frame: 25 years
Determine the DNA mutational pattern of breast epithelium from women at high risk for breast cancer.
Time frame: 25 years
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 10 Jan 2023.
- Background: PubMed 8292119Fisher B, Costantino J, Redmond C, Fisher E, Margolese R, Dimitrov N, Wolmark N, Wickerham DL, Deutsch M, Ore L, et al. Lumpectomy compared with lumpectomy and radiation therapy for the treatment of intraductal breast cancer. N Engl J Med. 1993 Jun 3;328(22):1581-6. doi: 10.1056/NEJM199306033282201.
- Background: PubMed 10735013Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
- Background: PubMed 10376613Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12;353(9169):1993-2000. doi: 10.1016/S0140-6736(99)05036-9.
- Derived from this study: PubMed 32753377Danforth DN, Filie AC, Warner AC, Wright GW, Sun Z, Ried T, McGowan CT, Prindiville SA. Characteristics of Breast Ducts in Normal-Risk and High-risk Women and Their Relationship to Ductal Cytologic Atypia. Cancer Prev Res (Phila). 2020 Dec;13(12):1027-1036. doi: 10.1158/1940-6207.CAPR-19-0305. Epub 2020 Aug 4.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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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.
David N Danforth, M.D. principal investigator
National Cancer Institute (NCI)
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 19 inclusion and 25 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 10 Jan 2023. 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.
What does the primary outcome measure?
Determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast. (time frame: 25 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00028340, which also lists 4 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 10 Jan 2023.