The Ultrasound Study of Tamoxifen

NCT01582074 | Completed

• 2 other identifiers: 99991119911-C-N199
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- 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. Objectives: \- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure. Eligibility: \- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer. Design:

• 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.

Conditions

Breast Neoplasms

Keywords

Ultrasound Tomography; Tamoxifen; Breast Cancer; Estrogen Receptor Positive; Breast Density

Outcome Measures

Primary Outcomes (1)

• Change in breast density

  Change in breast density

  12 month follow-up visit

Study Arms (2)

Cases

women with breast cancer

Controls

Matched women without breast cancer

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. Cases: 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.

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gretchen Benson, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: July 5, 2011
• Primary Completion: December 31, 2015
• Study Completion: January 1, 2016
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

US (1)