We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

The Ultrasound Study of Tamoxifen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01582074
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 28, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography scans can show changes in breast density. To examine these changes, healthy volunteers with no history of breast cancer and women who are taking tamoxifen will have ultrasound tomography scans.


- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure.


- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer.


  • All participants will have a screening visit. Healthy volunteers will have one additional study visit; women taking tamoxifen will have three additional study visits.
  • All participants will be screened with a physical exam and medical history. They will also give blood and saliva samples. This visit will also include an initial ultrasound tomography breast scan.
  • For the healthy volunteers:
  • At the study visit (12 months after the screening visit), participants will have a short interview and be weighed. They will also have an ultrasound tomography breast scan and provide a blood sample.
  • For the women taking tamoxifen:
  • At the second and third visits (1 to 3 months and 3 to 6 months after starting tamoxifen), participants will have a short interview. They will also be weighed and have an ultrasound tomography breast scan.
  • At the fourth visit (12 months after starting tamoxifen), participants will have a short interview, weight measurement, and the ultrasound tomography breast scan, and will also provide a blood sample.
  • All participants may be followed for up to 5 years after their final study visit.

Condition or disease
Breast Neoplasms

Detailed Description:
Elevated breast density is one of the strongest risk factors for non-familial breast cancer [1]. Recently, the International Breast Cancer Intervention Study-1 (IBIS-1) trial reported that women whose mammographic density declined by 10% within 12-18 months of initiating tamoxifen chemoprevention also had a marked reduction in cancer risk [2]; however, preliminary data suggested that in 30% of patients, tamoxifen failed to lower density and did not reduce cancer risk. Therefore, we hypothesize that breast density represents a biosensor of tamoxifen response, reflecting bioavailability and action of active drug metabolites. Distinguishing tamoxifen responders from non-responders at the earliest time point would have value for making informed treatment decisions, providing a rationale for continued therapy among responders while sparing non-responders exposure to ineffective treatment. We propose to use a novel ultrasound tomography (UST) scanner to repeatedly assess volumetric breast density among 150 women during their first year of tamoxifen use for clinical indications, including a referral from a health professional based on a woman s personal risk of breast cancer or a diagnosis of atypical lobular or ductal hyperplasia (ALH/ADH), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive breast cancer, to assess whether tamoxifen-related declines in mammographic density found at 12 months can be identified earlier with UST. UST is ideally suited for this application because it produces volumetric data and avoids artifacts secondary to breast compression and exposure to potentially harmful ionizing radiation. For comparison, we will perform UST on a group of 150 age-, race-, and menopausal status-matched women without breast cancer in order to assess changes in UST density over time without tamoxifen exposure. The specific goal of this project is to utilize UST to describe the early time course of volumetric breast density change. The broader objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination.

Layout table for study information
Study Type : Observational
Actual Enrollment : 247 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Ultrasound Study of Tamoxifen
Actual Study Start Date : July 5, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : January 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen

women with breast cancer
Matched women without breast cancer

Primary Outcome Measures :
  1. Change in breast density [ Time Frame: 12 month follow-up visit ]
    Change in breast density

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical
  • All Subjects:
  • Aged 30 to 70 at the baseline visit;
  • Weight is less than or equal to 350 lbs;
  • Not currently pregnant or breastfeeding;
  • No breast implants currently;
  • No active skin infections or wounds overlying the breast;
  • The breast, as visually assessed, can fit through the ultrasound tomography ring (i.e., 20 cm in diameter);
  • No serious medical or psychiatric illnesses that would prevent voluntary informed consent.


Is planning to take tamoxifen for clinical indications including:

  1. A referral from a health care professional based on a woman s personal risk of breast cancer (i.e., BRCA1/2 mutation carrier or 5-year predicted risk of breast cancer of greater than or equal to 1.66% according to the gail model [30]; OR
  2. A diagnosis with invasive, estrogen receptor positive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical lobular or ductal hyperplasia affecting one breast; AND
  3. Has never been diagnosed with breast cancer in the breast contralateral to the current diagnosis;

    • Is not receiving or currently planning to take chemotherapy.

Screen-negative Comparison Group:

  • The most recent mammogram resulted in recommendations for continued routine screening (i.e., BIRADS diagnostic score of 1 or "2");
  • Not currently taking oral contraceptives or menopausal hormone therapy;
  • Not been previously diagnosed with breast cancer or received medications or radiation for any type of cancer;
  • Not taking medicines (such as tamoxifen or raloxifene) to lower her breast cancer risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582074

Layout table for location information
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Gretchen Benson, Ph.D. National Cancer Institute (NCI)
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01582074    
Obsolete Identifiers: NCT01433783
Other Study ID Numbers: 999911199
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Ultrasound Tomography
Breast Cancer
Estrogen Receptor Positive
Breast Density
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases