Breast CancerNCT00989638
A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer
An observational study of Breast Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women. This would include Breast Mammography and Magnetic Resonance Imaging (MRI) examination of your breasts. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2004to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Women at high risk for breast cancer.
Who may be able to join
- Each woman will meet one or more of the criteria below:
- Known BRCA1 or BRCA2 carrier (must be older than 21 years)
- Any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). Some examples of these would include TP53, PTEN, BRCA1 and BRCA2, CHEK2, ATM, and CDH1 and other identified genetic markers conferring greater than 2.5 fold increased breast cancer risk in a polygenic model.
- For women who chose not to have genetic testing or test negative, probability of being a BRCA1 or BRCA2 carrier of 20% or greater based on BRCAPRO analysis or ≥ 25% risk of being a mutation carrier by any Genetic model such as Couch, Myriad, BODICEA, in addition to a lifetime breast cancer risk >=20% by CARE, Tyler Cuzick, or Claus model
- Personal history of breast cancer before age 35 years and no evidence of disease recurrence for at least two years.
- Any woman of African ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk model calculation
Show all 13Show fewer
- Have a personal history of ductal carcinoma in situ (DCIS) diagnosed at or before age 35 AND a first degree relative who had been diagnosed with breast cancer before age 50 OR has a first degree relative diagnosed with ovarian cancer at any age
- Any female cancer survivor who received chest irradiation before age 30 for any disease including Hodgkin's, a sarcoma, neuroblastoma, or other medical condition.
- In addition to meeting one of the above criteria, women must meet all of the following:
- willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
- have at least one breast that has not been irradiated for cancer
- be at least 25 years of age or at least 5 years younger than the first case of breast cancer diagnosis in the family. (This applies only to high risk women who are not BRCA1 or BRCA2 mutation carriers)
- be able to give informed consent
Who cannot join
- Women will be excluded if they meet one of the following:
- active cancer at the time of enrollment. A prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
- current pregnancy or plans for pregnancy within two years of enrollment
- presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI
- breast surgery within two weeks of study entry
- previous bilateral mastectomy (prophylactic or therapeutic)
- history of kidney disease or abnormal kidney tests
- Women who test negative in a family with identifiable BRCA mutations are ineligible regardless of risk calculation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women. This would include Breast Mammography and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago Department of Radiology is performing research to develop better ways of imaging the breast. The investigators would like to be able to reliably identify abnormal tissue and determine whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which involves removing breast tissue with a needle or surgical instrument). Annual mammography has already been recommended for the patient based on family history or personal history of cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on breast cancer screening (mammograms). MRI, in combination with mammography, may increase the rate of detection of early cancers. In addition, MRI can provide better images of breast tissue. The investigators hope to prove that combining multiple screening measures including biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be found early. This study will also evaluate quality of life measures during breast cancer screening and compare breast MRI and mammogram in a high-risk population. The investigators will establish a database of clinical characteristics, blood biomarkers and interventions that will be saved for future analysis and aid in the development of more effective screening in high-risk women. This research will also help us develop tools for studies in the future.
- Conditions
- Breast Cancer
- 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 |
|---|---|---|
| Women at high risk for breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women
Measured: Until enrollment is complete
Impact of intensive breast cancer screening on patient reported outcomes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study start23 Jun 2004
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of ChicagoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo Olopade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989638
- Sponsor's protocol ID
- 13073B
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2009
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guindalini RSC, Zheng Y, Abe H, Whitaker K, Yoshimatsu TF, Walsh T, Schacht D, Kulkarni K, Sheth D, Verp MS, Bradbury AR, Churpek J, Obeid E, Mueller J, Khramtsova G, Liu F, Raoul A, Cao H, Romero IL, Hong S, Livingston R, Jaskowiak N, Wang X, Debiasi M, Pritchard CC, King MC, Karczmar G, Newstead GM, Huo D, Olopade OI. Intensive Surveillance with Biannual Dynamic Contrast-Enhanced Magnetic Resonance Imaging Downstages Breast Cancer in BRCA1 Mutation Carriers. Clin Cancer Res. 2019 Mar 15;25(6):1786-1794. doi: 10.1158/1078-0432.CCR-18-0200. Epub 2018 Aug 28.
PubMed 30154229
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT00989638
- Acronym / sponsor ID
- 13073B
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 23 Jun 2004 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Oct 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.
The purpose of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women. This would include Breast Mammography and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago Department of Radiology is performing research to develop better ways of imaging the breast. The investigators would like to be able to reliably identify abnormal tissue and determine whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which involves removing breast tissue with a needle or surgical instrument). Annual mammography has already been recommended for the patient based on family history or personal history of cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on breast cancer screening (mammograms). MRI, in combination with mammography, may increase the rate of detection of early cancers. In addition, MRI can provide better images of breast tissue. The investigators hope to prove that combining multiple screening measures including biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be found early. This study will also evaluate quality of life measures during breast cancer screening and compare breast MRI and mammogram in a high-risk population. The investigators will establish a database of clinical characteristics, blood biomarkers and interventions that will be saved for future analysis and aid in the development of more effective screening in high-risk women. This research will also help us develop tools for studies in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women at high risk for breast cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women at high risk for breast cancer.
Key inclusion criteria (13 listed)
- Known BRCA1 or BRCA2 carrier (must be older than 21 years)
- Any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). Some examples of these would include TP53, PTEN, BRCA1 and BRCA2, CHEK2, ATM, and CDH1 and other identified genetic markers conferring greater than 2.5 fold increased breast cancer risk in a polygenic model.
- For women who chose not to have genetic testing or test negative, probability of being a BRCA1 or BRCA2 carrier of 20% or greater based on BRCAPRO analysis or ≥ 25% risk of being a mutation carrier by any Genetic model such as Couch, Myriad, BODICEA, in addition to a lifetime breast cancer risk >=20% by CARE, Tyler Cuzick, or Claus model
- Personal history of breast cancer before age 35 years and no evidence of disease recurrence for at least two years.
- Any woman of African ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk model calculation
Key exclusion criteria (8 listed)
- active cancer at the time of enrollment. A prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
- current pregnancy or plans for pregnancy within two years of enrollment
- presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI
- breast surgery within two weeks of study entry
- previous bilateral mastectomy (prophylactic or therapeutic)
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
Creation of registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women
Time frame: Until enrollment is complete
Impact of intensive breast cancer screening on patient reported outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 30154229Guindalini RSC, Zheng Y, Abe H, Whitaker K, Yoshimatsu TF, Walsh T, Schacht D, Kulkarni K, Sheth D, Verp MS, Bradbury AR, Churpek J, Obeid E, Mueller J, Khramtsova G, Liu F, Raoul A, Cao H, Romero IL, Hong S, Livingston R, Jaskowiak N, Wang X, Debiasi M, Pritchard CC, King MC, Karczmar G, Newstead GM, Huo D, Olopade OI. Intensive Surveillance with Biannual Dynamic Contrast-Enhanced Magnetic Resonance Imaging Downstages Breast Cancer in BRCA1 Mutation Carriers. Clin Cancer Res. 2019 Mar 15;25(6):1786-1794. doi: 10.1158/1078-0432.CCR-18-0200. Epub 2018 Aug 28.
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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.
Olufunmilayo Olopade, MD principal investigator
University of Chicago
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 University of Chicago 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 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Creation of registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women (time frame: Until enrollment is complete). The study lists 2 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 NCT00989638, which also lists 1 linked publication.
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 1 Oct 2025.