Breast Ultrasound and Mammography in Screening Women at High Risk for Breast Cancer

NCT00072501 | Completed

• 2 other identifiers: CDR0000339812ACRIN-6666
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Breast Cancer

Keywords

breast cancer

Interventions

breast imaging study PROCEDURE

comparison of screening methods PROCEDURE

magnetic resonance imaging PROCEDURE

radiomammography PROCEDURE

ultrasound imaging PROCEDURE

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 dialysis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Invision - Radiology Imaging Associates

Greenwood Village, Colorado, 80111, United States

Location

Radiology Associates of Atlanta

Atlanta, Georgia, 30309, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Johns Hopkins at Green Spring Station

Lutherville, Maryland, 21093, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219, United States

Location

Radiology Consultants, Incorporated

Youngstown, Ohio, 44512, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, 15206, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Centro de Estudios Radilogicos Integrales de la Mama - Buenos Aires

Buenos Aires, 1115, Argentina

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (10)

• Berg 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 BACKGROUND

• Madsen 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 BACKGROUND

• Berg 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 BACKGROUND

• Berg 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 BACKGROUND

• Berg 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 RESULT

• Berg 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 RESULT

• Berg 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.

  PMID: 20032143 RESULT

• Berg WA, Sechtin AG, Marques H, Zhang Z. Cystic breast masses and the ACRIN 6666 experience. Radiol Clin North Am. 2010 Sep;48(5):931-87. doi: 10.1016/j.rcl.2010.06.007.

  PMID: 20868895 RESULT

• Berg 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 RESULT

• Berg WA, Bandos AI, Mendelson EB, Lehrer D, Jong RA, Pisano ED. Ultrasound as the Primary Screening Test for Breast Cancer: Analysis From ACRIN 6666. J Natl Cancer Inst. 2015 Dec 28;108(4):djv367. doi: 10.1093/jnci/djv367. Print 2016 Apr.

  PMID: 26712110 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Wendie A. Berg, MD, PhD

  Johns Hopkins at Green Spring Station

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SCREENING
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: April 1, 2004
• Primary Completion: April 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2006-02

Locations

US (18); AR (1); CA (1)