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New screening combo could catch breast cancer earlier in High-Risk women
NCT ID NCT00989638
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether combining mammograms with breast MRIs can find breast cancer earlier in women at high risk, such as those with BRCA gene mutations. About 305 participants will get both scans yearly, and researchers will track how well they detect cancer and how the screening affects quality of life. The goal is to create a better, less invasive screening program that reduces the need for biopsies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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305 people
The number who actually took part.
- Started
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Jun 2004
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women at high risk for breast cancer.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 * 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 Exclusion Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Chicago
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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