A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.

Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone. Primary Objective: For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast cancer screening modality and compare it to that of XRM alone. Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS. Endpoint: Breast cancers detected by radiologists in the clinical screening setting and confirmed by pathology. Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000 women with parenchymal density \> 50% on digital x-ray mammography (XRM). Participants will receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded.

Sex

Female

Minimum age

25 Years

Inclusion Criteria:

* Female
* Asymptomatic
* Prior screening mammograms, if available, exhibit history of breast density
* Not currently pregnant or breastfeeding
* Not planning to become pregnant in the following 18 months
* Age 25 or older
* No breast surgeries or interventional procedures in the past 12 months
* No history of cancer diagnosis and/or treatment in the past 12 months
* Informed Consent and Completed Participant Questionnaire
* Complete screening mammography views (CC and MLO) for one or both breasts
* \> 50% preliminary parenchymal density on preliminary assessment by technologist
* Willing to comply with study protocol and follow-up recommendations:

  * If evaluation is normal, must undergo routine screening mammography in 12 months
  * If evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the Investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
  * Agrees to report any breast changes or symptoms to the Investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
  * Agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.

Exclusion Criteria:

* ≤ 50% preliminary parenchymal density on preliminary assessment by technologist
* Does not meet all Inclusion Criteria for Enrollment

• BACKGROUNDDuffy SW, Tabar L, Chen HH, Holmqvist M, Yen MF, Abdsalah S, Epstein B, Frodis E, Ljungberg E, Hedborg-Melander C, Sundbom A, Tholin M, Wiege M, Akerlund A, Wu HM, Tung TS, Chiu YH, Chiu CP, Huang CC, Smith RA, Rosen M, Stenbeck M, Holmberg L. The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer. 2002 Aug 1;95(3):458-69. doi: 10.1002/cncr.10765. PMID 12209737
• BACKGROUNDBerg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Bohm-Velez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008 May 14;299(18):2151-63. doi: 10.1001/jama.299.18.2151. PMID 18477782
• BACKGROUNDBoyd NF, Martin LJ, Yaffe MJ, Minkin S. Mammographic density: a hormonally responsive risk factor for breast cancer. J Br Menopause Soc. 2006 Dec;12(4):186-93. doi: 10.1258/136218006779160436. PMID 17178021
• BACKGROUNDUrsin G, Hovanessian-Larsen L, Parisky YR, Pike MC, Wu AH. Greatly increased occurrence of breast cancers in areas of mammographically dense tissue. Breast Cancer Res. 2005;7(5):R605-8. doi: 10.1186/bcr1260. Epub 2005 Jun 8. PMID 16168104
• BACKGROUNDTorres-Mejia G, De Stavola B, Allen DS, Perez-Gavilan JJ, Ferreira JM, Fentiman IS, Dos Santos Silva I. Mammographic features and subsequent risk of breast cancer: a comparison of qualitative and quantitative evaluations in the Guernsey prospective studies. Cancer Epidemiol Biomarkers Prev. 2005 May;14(5):1052-9. doi: 10.1158/1055-9965.EPI-04-0717. PMID 15894652
• BACKGROUNDBoyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36. doi: 10.1056/NEJMoa062790.