Clinical trial · Interventional
Breast Ultrasound and Mammography in Screening Women at High Risk for Breast Cancer
Screening Breast Ultrasound in High-Risk Women
NCT00072501CI-TRIAL-00008366completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer cells early and plan more effective treatment for breast cancer. It is not yet known whether ultrasound is more effective than mammography in detecting breast cancer. PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast imaging study | Procedure | — | UNRESOLVED |
| comparison of screening methods | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| radiomammography | Procedure | — | UNRESOLVED |
| ultrasound imaging | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* At high risk for breast cancer, as defined by at least 1 of the following:
* Known BRCA1 or BRCA2 mutation
* Personal history of breast cancer with conserved breast analyzed separately
* Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention (i.e., not on tamoxifen, raloxifene, anastrazole, or any other aromatase inhibitor) OR any of these atypical lesions (including phyllodes tumors) AND first-degree relative diagnosed with breast cancer under age 50
* Prior biopsy showing lobular carcinoma in situ
* Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation ≥ 8 years ago
* Risk of breast cancer meeting one of the following criteria:
* Gail or Claus lifetime cancer risk ≥ 25%
* Gail 5-year cancer risk ≥ 2.5%
* Gail 5-year cancer risk ≥ 1.7% AND known to have extremely dense breasts (≥ 75% dense) by most recent mammogram
* Heterogeneously dense (≥ 50% dense) or extremely dense (≥ 75% dense throughout the entire breast) breast parenchyma in at least 1 breast by mammogram\* OR unknown breast density due to no prior mammogram NOTE: \*No fatty breasts or minimal scattered fibroglandular density
* Most recent mammogram\* (if any) was interpreted as negative, benign, and/or remarkable only for post-treatment changes NOTE: \*At least 11 full months since prior mammogram
* No current signs or symptoms of breast cancer (e.g., palpable breast masses, bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast\[s\] or nipple\[s\])
* History of breast cancer allowed provided ≥ 1 year has elapsed since the last treatment with surgery and there is no known distant metastases and no known residual tumor
* No bilateral breast implants
* Participants with a unilateral breast implant who would otherwise be eligible for study participation allowed (only breast without implant is evaluated)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 25 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Glomerular filtration rate ≥ 30 mL/min
Other
* Not pregnant or nursing
* Fertile participants must use effective contraception
* Able to undergo adequate mammography and cooperate with breast ultrasound
* No concurrent medical or psychiatric condition that would preclude biopsy
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindications to MRI (e.g., pacemaker, aneurysm clip, or other implanted magnetic device)\*
* No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative\*
* Must have intravenous access\*
* Weight \< 300 pounds\*
* Physically able to tolerate positioning in the MRI scanner\*
* Able to undergo contrast-enhanced MRI within 4 weeks after completing both study ultrasound and mammogram at 24-month time point\*
* Agrees to undergo follow-up MRI at 6 months and/or MRI-guided vacuum-assisted biopsy or ultrasound-guided core biopsy (if needed)\* NOTE: \*MRI component of the study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No concurrent chemotherapy (MRI component of the study)
Endocrine therapy
* See Disease Characteristics
* Concurrent chemoprevention with tamoxifen, raloxifene, anastrozole, exemestane or other aromatase inhibitor for participants with a personal history of cancer allowed (MRI component of the study)
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
* More than 1 year since prior fine needle aspiration, core needle biopsy, or surgical procedure
* No prior bilateral mastectomy (MRI component of the study)
* More than 1 year since prior breast surgery on the study breast(s) (MRI component of the study)
* More than 5 months since prior core biopsy of the study breast(s) (MRI component of the study)
Other
* More than 1 year since prior contrast-enhanced MRI of the breast
* More than 1 year (≥ 11 full months) since prior whole breast bilateral ultrasound
* More than 1 year since prior sonographic or mammographic contrast agent injection or tomosynthesis
* More than 2 years since prior screening contrast-enhanced MRI of the study breast(s) (MRI component of the study)
* More than 1 year since prior diagnostic contrast-enhanced MRI of the study breast(s) (MRI component of the study)
* No concurrent participation in any other breast cancer screening trial
* No concurrent participation in any other study involving breast MRI, sonographic or mammographic contrast agents, or tomosynthesis
* No concurrent dialysisReferences
Publications (10)
- BACKGROUNDBerg WA, Blume JD, Cormack JB, Mendelson EB, Madsen EL; ACRIN 6666 Investigators. Lesion detection and characterization in a breast US phantom: results of the ACRIN 6666 Investigators. Radiology. 2006 Jun;239(3):693-702. doi: 10.1148/radiol.2393051069. Epub 2006 Apr 26. PMID 16641344
- BACKGROUNDMadsen EL, Berg WA, Mendelson EB, Frank GR; Investigators for ACRIN Protocol 6666. Anthropomorphic breast phantoms for qualification of Investigators for ACRIN Protocol 6666. Radiology. 2006 Jun;239(3):869-74. doi: 10.1148/radiol.2393051070. Epub 2006 Apr 26. PMID 16641345
- BACKGROUNDBerg WA. Supplemental screening sonography in dense breasts. Radiol Clin North Am. 2004 Sep;42(5):845-51, vi. doi: 10.1016/j.rcl.2004.04.003. PMID 15337420
- BACKGROUNDBerg WA. Rationale for a trial of screening breast ultrasound: American College of Radiology Imaging Network (ACRIN) 6666. AJR Am J Roentgenol. 2003 May;180(5):1225-8. doi: 10.2214/ajr.180.5.1801225. No abstract available. PMID 12704027
- RESULTBerg WA, Blume JD, Cormack JB, Mendelson EB. Training the ACRIN 6666 Investigators and effects of feedback on breast ultrasound interpretive performance and agreement in BI-RADS ultrasound feature analysis. AJR Am J Roentgenol. 2012 Jul;199(1):224-35. doi: 10.2214/AJR.11.7324. PMID 22733916
- RESULTBerg WA, Zhang Z, Lehrer D, Jong RA, Pisano ED, Barr RG, Bohm-Velez M, Mahoney MC, Evans WP 3rd, Larsen LH, Morton MJ, Mendelson EB, Farria DM, Cormack JB, Marques HS, Adams A, Yeh NM, Gabrielli G; ACRIN 6666 Investigators. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012 Apr 4;307(13):1394-404. doi: 10.1001/jama.2012.388. PMID 22474203
- RESULTBerg WA, Blume JD, Adams AM, Jong RA, Barr RG, Lehrer DE, Pisano ED, Evans WP 3rd, Mahoney MC, Hovanessian Larsen L, Gabrielli GJ, Mendelson EB. Reasons women at elevated risk of breast cancer refuse breast MR imaging screening: ACRIN 6666. Radiology. 2010 Jan;254(1):79-87. doi: 10.1148/radiol.2541090953.