Breast CancerNCT00006421
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-Up Study
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 2-Fluorodeoxyglucose
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2000to not given
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriers /non-carriers using two imaging modalities: mammography and MRI. This is a prospective cohort study of 200 women to gather data on the evolution of epithelial cell/molecular changes in BRCA1/2 mutation carriers, by collecting/analyzing NAF, BDL fluid, biopsy tissues (when indicated), and serum/lymphocytes; samples are stored for future studies. Eligible study participants include: 1)Women 25-56 years of age carrying a known deleterious mutation; 2) BRCA1/2@@@Women between the ages of 25 56 who are first- or second- degree relatives of individuals with a deleterious mutation. BRCA1/2, and 3)Women aged 25-56 who are first- or second- degree relatives of individuals with associated cancers in families with documented BRCA- BRCA mutations.
Who may be able to join
- To participate in the Annual Follow-up Study, a woman must:
- Be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 56 years of age.
- Must be:
- A known BRCA1 or BRCA2 deleterious mutation carrier
- OR
- A first- or second- degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation
Show all 13Show fewer
- OR
- A first- or second- degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation.
- Have undergone genetic counseling and risk assessment.
- Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making.
- Have an ECOG performance status of 0-1.
- Be able to provide informed consent.
- Have at least one non-irradiated breast.
Who cannot join
- Any of the following will result in exclusion from the Annual Follow-up Study:
- Pregnancy or lactation within 6 months of enrollment.
- Abnormal CA-125 level.
- Bilateral breast cancer, ovarian (any stage) or breast cancer (Stage IIB or worse) unless relapse free for 5 years prior to the time of enrollment.
- Patients with DCIS, Stage I and Stage II breast cancer are eligible provided that it has been at least 6 months from the completion of primary therapy (surgery, radiation, and chemotherapy as applicable). Tamoxifen and aromatase inhibitor adjuvant therapy is allowed.
- Patients with DCIS, Stage I and Stage II breast cancer who have had a local relapse after primary treatment are not eligible unless they have been relapse free for 5 years prior to the time of enrollment.
Show all 15Show fewer
- History of other invasive cancer unless relapse free for 5 years prior to the time of enrollment. Non-Melanoma skin cancer or cervical carcinoma in situ are excepted.
- Previous bilateral mastectomy or bilateral radiation therapy.
- Weigh over 136 kilograms.
- Allergy to gadolinium.
- Allergy to lidocaine or Marcaine (bupivacaine). (excluded from breast duct lavage only).
- Subareolar or other surgery of the breast to be studied which might disrupt the ductal systems. For example, papilloma resection, biopsy or fine needle aspirations (FNAs) within 2 cm of the nipple might disrupt the ductal systems. Biopsies or FNAs greater than 2 cm from the nipple are acceptable. (Excluded from ductal lavage only)
- A breast implant or prior silicone injections in the breast to be studied. (Exclude from breast ductal lavage only)
- Active infections or inflammation in a breast to be studied. (breast ductal lavage only)
- Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research.
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: Breast Imaging Screening Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-up Study
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene.
Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or 99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study.
Read more
At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors, family and personal history of cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and previous surgery on the breasts and ovaries. In addition, they will undergo the following procedures:
Routine breast and ovarian cancer screening for high-risk women, including a mammogram, breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and transvaginal ultrasound of the ovaries.
Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues.
Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes.
Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation. This diagnostic test is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels.
Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above, blood draw, update of family history and risk factors, breast MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further evaluation, the PET will be repeated.
Read the detailed description
Background:
- Women who carry mutations in genes such as BRCA1/2 have a higher lifetime risk of breast cancer (BC) and are at risk of developing BC at earlier ages than women in the general population.
- Prophylactic mastectomy and/or oophorectomy may be used to decrease risk and intensified mammographic and magnetic resonance imaging (MRI) surveillance may allow earlier diagnosis; however, prophylactic mastectomy has not been shown to convey survival advantage over more conservative management.
- Greater breast tissue density and low BC incidence result in a lower positive predictive value of mammography in premenopausal women as compared to postmenopausal women (PPV=0.04 for women aged 40-49).
- This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriers/non-carriers using two imaging modalities: mammography and MRI.
- Nipple Aspiration Fluid collection (NAF) and breast duct lavage will be used to obtain cytologic materials which may be used as an adjunct to breast imaging for the early detection of epithelial atypia and pre-invasive cancer.
Objectives:
- Compare four outcomes including two mammographic density measures (qualitative and semiquantitative), fibroglandular volume measure using MRI, and contrast enhancement measure using MRI (both semiquantitative) in mutation carriers/non-carriers to improve lesion detection
- Explore non-ionizing approaches (MRI) to BC screening because the effects of ionizing radiation due to mammography are unknown.
- Use NAF and/or BDL to obtain epithelial cell samples and correlate cytologic and imaging findings.
- Gather prospective data on the transformation from normal/hyperplastic/pre-invasive/invasive disease in BRCA1/2 mutation carriers/non-carriers through molecular/genetic studies of breast tissue (via biopsy of radiographic abnormalities) or breast fluid (via BDL and/or nipple aspiration) and develop molecular markers for early detection of epithelial atypia/pre-invasive cancer.
- Assess the psychosocial impact of participation in a BC screening program.
Eligibility:
- Women 25-56 years of age carrying a known BRCA1/2 deleterious mutation.
- Women between the ages of 25 -56 who are first- or second- degree relatives of individuals with a deleterious BRCA1/2 mutation.
- Women aged 25-56 who are first- or second- degree relatives of individuals with BRCA-associated cancers in families with documented BRCA mutations.
Design:
- Prospective cohort study of 200 women to gather data on the evolution of epithelial cell/molecular changes in BRCA1/2 mutation carriers, by collecting/analyzing NAF, BDL fluid, biopsy tissues (when indicated), and serum/lymphocytes; samples are stored for future studies.
- Women complete questionnaires and undergo breast/pelvis examination, transvaginal ultrasonography, serum pregnancy test, fasting glucose, electrolytes, BUN, creatinine and CA 125. Standard four view mammogram and breast MRI are performed on study entry and annually for three additional years.
- Conditions
- Breast Cancer
- Being tested
- 2-Fluorodeoxyglucose
- Keywords
- Breast MRI, Nipple Aspirate Fluid, Transvaginal ultrasound, Ductal lavage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-FluorodeoxyglucoseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in measures of mammographic density and MRI fibroglandular volume between mutation positive and mutation negative women
Compare four outcomes including two mammographic density measures (qualitative and semi-quantitative), fibroglandular volume measure using MRI, and contrast enhancement measure using MRI (both semiquantitative) in mutation carriers/non-carriers to improve lesion detection
Measured: 1/1/2001-12/31/2011
Cytologic cell counts, mammographic density and MRI fibroglandular volume
Use NAF and/or BDL to obtain epithelial cell samples and correlate cytologic and imaging findings.
Measured: 1/1/2001-12/31/2011
Obtain biologic materials in participants who undergo clinically indicated surgical procedures and NAF/BDL over time and correlate with outcomes of breast screening.
Gather prospective data on the transformation from normal/hyperplastic/pre-invasive/invasive disease in BRCA1/2 mutation carriers/non-carriers through molecular/genetic studies of breast tissue (via biopsy of radiographic abnormalities) or breast fluid (via BDL and/or nipple aspiration) and develop molecular markers for early detection of epithelial atypia/pre-invasive cancer.
Measured: 1/1/2001-12/31/2011
Use questionnaires and interviews to evaluate the impact, emotional outcomes and decision-making in study participants
Assess the psychosocial impact of participation in a BC screening program.
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2000 (estimated)
- Study start25 Oct 2000
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sharon A Savage, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006421
- Sponsor's protocol ID
- 010009
- Other IDs
- 01-C-0009
- Status last verified
- 7 May 2026
- First submitted
- 27 Oct 2000
- Last updated
- 29 Oct 2026
- Results posted
- No
Publications
Koehly LM, Peters JA, Kenen R, Hoskins LM, Ersig AL, Kuhn NR, Loud JT, Greene MH. Characteristics of health information gatherers, disseminators, and blockers within families at risk of hereditary cancer: implications for family health communication interventions. Am J Public Health. 2009 Dec;99(12):2203-9. doi: 10.2105/AJPH.2008.154096. Epub 2009 Oct 15.
PubMed 19833996Loud JT, Thiebaut AC, Abati AD, Filie AC, Nichols K, Danforth D, Giusti R, Prindiville SA, Greene MH. Ductal lavage in women from BRCA1/2 families: is there a future for ductal lavage in women at increased genetic risk of breast cancer? Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1243-51. doi: 10.1158/1055-9965.EPI-08-0795. Epub 2009 Mar 31.
PubMed 19336560Gierach GL, Loud JT, Chow CK, Prindiville SA, Eng-Wong J, Soballe PW, Giambartolomei C, Mai PL, Galbo CE, Nichols K, Calzone KA, Vachon C, Gail MH, Greene MH. Mammographic density does not differ between unaffected BRCA1/2 mutation carriers and women at low-to-average risk of breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):245-55. doi: 10.1007/s10549-010-0749-7. Epub 2010 Feb 4.
PubMed 20130984Ersig AL, Werner-Lin A, Hoskins L, Young J, Loud JT, Peters J, Greene MH. Legacies and Relationships: Diverse Social Networks and BRCA1/2 Risk Management Decisions and Actions. J Fam Nurs. 2019 Feb;25(1):28-53. doi: 10.1177/1074840718815844. Epub 2018 Dec 12.
PubMed 30537877
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Imaging Screening Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-up Study
- ClinicalTrials.gov ID
- NCT00006421
- Acronym / sponsor ID
- 010009
- Conditions
- Breast Cancer
- Keywords
- Breast MRI, Nipple Aspirate Fluid, Transvaginal ultrasound, Ductal lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 25 Oct 2000 (actual)
- First posted
- 30 Oct 2000 (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.
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene.
Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or 99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study.
At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors, family and personal history of cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and previous surgery on the breasts and ovaries. In addition, they will undergo the following procedures:
Routine breast and ovarian cancer screening for high-risk women, including a mammogram, breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and transvaginal ultrasound of the ovaries.
Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues.
Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes.
Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation. This diagnostic test is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels.
Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above, blood draw, update of family history and risk factors, breast MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further evaluation, the PET will be repeated.
Detailed description
Background:
- Women who carry mutations in genes such as BRCA1/2 have a higher lifetime risk of breast cancer (BC) and are at risk of developing BC at earlier ages than women in the general population.
- Prophylactic mastectomy and/or oophorectomy may be used to decrease risk and intensified mammographic and magnetic resonance imaging (MRI) surveillance may allow earlier diagnosis; however, prophylactic mastectomy has not been shown to convey survival advantage over more conservative management.
- Greater breast tissue density and low BC incidence result in a lower positive predictive value of mammography in premenopausal women as compared to postmenopausal women (PPV=0.04 for women aged 40-49).
- This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriers/non-carriers using two imaging modalities: mammography and MRI.
- Nipple Aspiration Fluid collection (NAF) and breast duct lavage will be used to obtain cytologic materials which may be used as an adjunct to breast imaging for the early detection of epithelial atypia and pre-invasive cancer.
Objectives:
- Compare four outcomes including two mammographic density measures (qualitative and semiquantitative), fibroglandular volume measure using MRI, and contrast enhancement measure using MRI (both semiquantitative) in mutation carriers/non-carriers to improve lesion detection
- Explore non-ionizing approaches (MRI) to BC screening because the effects of ionizing radiation due to mammography are unknown.
- Use NAF and/or BDL to obtain epithelial cell samples and correlate cytologic and imaging findings.
- Gather prospective data on the transformation from normal/hyperplastic/pre-invasive/invasive disease in BRCA1/2 mutation carriers/non-carriers through molecular/genetic studies of breast tissue (via biopsy of radiographic abnormalities) or breast fluid (via BDL and/or nipple aspiration) and develop molecular markers for early detection of epithelial atypia/pre-invasive cancer.
- Assess the psychosocial impact of participation in a BC screening program.
Eligibility:
- Women 25-56 years of age carrying a known BRCA1/2 deleterious mutation.
- Women between the ages of 25 -56 who are first- or second- degree relatives of individuals with a deleterious BRCA1/2 mutation.
- Women aged 25-56 who are first- or second- degree relatives of individuals with BRCA-associated cancers in families with documented BRCA mutations.
Design:
- Prospective cohort study of 200 women to gather data on the evolution of epithelial cell/molecular changes in BRCA1/2 mutation carriers, by collecting/analyzing NAF, BDL fluid, biopsy tissues (when indicated), and serum/lymphocytes; samples are stored for future studies.
- Women complete questionnaires and undergo breast/pelvis examination, transvaginal ultrasonography, serum pregnancy test, fasting glucose, electrolytes, BUN, creatinine and CA 125. Standard four view mammogram and breast MRI are performed on study entry and annually for three additional years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriers /non-carriers using two imaging modalities: mammography and MRI. This is a prospective cohort study of 200 women to gather data on the evolution of epithelial cell/molecular changes in BRCA1/2 mutation carriers, by collecting/analyzing NAF, BDL fluid, biopsy tissues (when indicated), and serum/lymphocytes; samples are stored for future studies. Eligible study participants include: 1)Women 25-56 years of age carrying a known deleterious mutation; 2) BRCA1/2@@@Women between the ages of 25 56 who are first- or second- degree relatives of individuals with a deleterious mutation. BRCA1/2, and 3)Women aged 25-56 who are first- or second- degree relatives of individuals with associated cancers in families with documented BRCA- BRCA mutations.
Key inclusion criteria (13 listed)
- Be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 56 years of age.
- A known BRCA1 or BRCA2 deleterious mutation carrier
- OR
- A first- or second- degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation
- OR
Key exclusion criteria (15 listed)
- Pregnancy or lactation within 6 months of enrollment.
- Abnormal CA-125 level.
- Bilateral breast cancer, ovarian (any stage) or breast cancer (Stage IIB or worse) unless relapse free for 5 years prior to the time of enrollment.
- Patients with DCIS, Stage I and Stage II breast cancer are eligible provided that it has been at least 6 months from the completion of primary therapy (surgery, radiation, and chemotherapy as applicable). Tamoxifen and aromatase inhibitor adjuvant therapy is allowed.
- Patients with DCIS, Stage I and Stage II breast cancer who have had a local relapse after primary treatment are not eligible unless they have been relapse free for 5 years prior to the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-Fluorodeoxyglucose | Drug | – |
Primary outcome
Differences in measures of mammographic density and MRI fibroglandular volume between mutation positive and mutation negative women
Time frame: 1/1/2001-12/31/2011
Compare four outcomes including two mammographic density measures (qualitative and semi-quantitative), fibroglandular volume measure using MRI, and contrast enhancement measure using MRI (both semiquantitative) in mutation carriers/non-carriers to improve lesion detection
Cytologic cell counts, mammographic density and MRI fibroglandular volume
Time frame: 1/1/2001-12/31/2011
Use NAF and/or BDL to obtain epithelial cell samples and correlate cytologic and imaging findings.
Obtain biologic materials in participants who undergo clinically indicated surgical procedures and NAF/BDL over time and correlate with outcomes of breast screening.
Time frame: 1/1/2001-12/31/2011
Gather prospective data on the transformation from normal/hyperplastic/pre-invasive/invasive disease in BRCA1/2 mutation carriers/non-carriers through molecular/genetic studies of breast tissue (via biopsy of radiographic abnormalities) or breast fluid (via BDL and/or nipple aspiration) and develop molecular markers for early detection of epithelial atypia/pre-invasive cancer.
Use questionnaires and interviews to evaluate the impact, emotional outcomes and decision-making in study participants
Time frame: Study period
Assess the psychosocial impact of participation in a BC screening program.
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 29 Oct 2026.
- Background: PubMed 19833996Koehly LM, Peters JA, Kenen R, Hoskins LM, Ersig AL, Kuhn NR, Loud JT, Greene MH. Characteristics of health information gatherers, disseminators, and blockers within families at risk of hereditary cancer: implications for family health communication interventions. Am J Public Health. 2009 Dec;99(12):2203-9. doi: 10.2105/AJPH.2008.154096. Epub 2009 Oct 15.
- Background: PubMed 19336560Loud JT, Thiebaut AC, Abati AD, Filie AC, Nichols K, Danforth D, Giusti R, Prindiville SA, Greene MH. Ductal lavage in women from BRCA1/2 families: is there a future for ductal lavage in women at increased genetic risk of breast cancer? Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1243-51. doi: 10.1158/1055-9965.EPI-08-0795. Epub 2009 Mar 31.
- Background: PubMed 20130984Gierach GL, Loud JT, Chow CK, Prindiville SA, Eng-Wong J, Soballe PW, Giambartolomei C, Mai PL, Galbo CE, Nichols K, Calzone KA, Vachon C, Gail MH, Greene MH. Mammographic density does not differ between unaffected BRCA1/2 mutation carriers and women at low-to-average risk of breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):245-55. doi: 10.1007/s10549-010-0749-7. Epub 2010 Feb 4.
- Derived from this study: PubMed 30537877Ersig AL, Werner-Lin A, Hoskins L, Young J, Loud JT, Peters J, Greene MH. Legacies and Relationships: Diverse Social Networks and BRCA1/2 Risk Management Decisions and Actions. J Fam Nurs. 2019 Feb;25(1):28-53. doi: 10.1177/1074840718815844. Epub 2018 Dec 12.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Sharon A Savage, 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 13 inclusion and 15 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 29 Oct 2026. 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?
Differences in measures of mammographic density and MRI fibroglandular volume between mutation positive and mutation negative women (time frame: 1/1/2001-12/31/2011). The study lists 4 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 NCT00006421, 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 29 Oct 2026.