News | Breast Density | June 19, 2018

Clinical Trial Testing Topical Gel to Reduce Breast Density

Trial at USC Norris Comprehensive Cancer Center examines the effectiveness of 4-hydroxytamoxifen at reducing breast density, potentially lowering cancer risk and increasing diagnostic visibility

Clinical Trial Testing Topical Gel to Reduce Breast Density

June 19, 2018 — Women with dense breast tissue soon might be adding a new product to their skincare routine to help them fight breast cancer. A clinical trial at USC Norris Comprehensive Cancer Center is testing whether a topical gel containing 4-hydroxytamoxifen (4-OHT) is effective at decreasing breast tissue density, which may lower a woman’s risk of developing breast cancer. Additionally, the gel may reduce the need for supplemental testing for breast cancer, saving women time, money and anxiety.

Approximately half of women in the United States have dense fibroglandular breast tissue, which is unrelated to breast size or shape. While research has yet to confirm the cause of dense breasts, they have been linked with higher levels of estrogen. Women with dense breasts are at a sixfold increased risk for developing breast cancer. The long-term objective of the study is to determine whether decreasing fibroglandular breast density can prevent breast cancer, or if high breast density is simply a marker for increased risk.

Dense breast tissue also causes diagnostic challenges because it appears white and opaque on a mammogram. This can obstruct the view of tumors, which also appear white and opaque. Women with dense breasts who are at a high risk of developing breast cancer frequently require further examinations to confirm the absence of tumors. Further testing incurs additional time, cost and stress for the patient, who nervously waits to clarify her inconclusive mammogram results.

“To help women with dense breast tissue fight cancer, we need a deeper understanding about the nature of breast density as well as imaging techniques that can easily detect tumors more easily,” said the trial’s principal investigator at USC Norris, Pulin Sheth, M.D., director of the breast center at USC Norris and assistant professor of clinical radiology at the Keck School of Medicine of USC. “We are excited to assess a clinical innovation that could potentially fulfill both of those needs through a simple daily topical application.”   

The clear, odorless gel has the look and feel of hand sanitizer and absorbs just as quickly. Women with dense breast tissue would apply the gel directly to the breast after bathing, incorporating the product into their daily skincare routine. The gel has no effect on the outward appearance of the breasts.

4-OHT is a byproduct of tamoxifen, a commonly prescribed oral cancer therapy that blocks the estrogen that breast cancer tumors need to grow. When a patient takes oral tamoxifen, her liver metabolizes the drug and sends 4-OHT to the breasts, where it binds with the tumor’s hormone receptors and keeps estrogen away. However, other metabolized byproducts of the drug circulate through the bloodstream to different areas of the body, which can cause side effects like hot flashes, clotting issues and vaginal bleeding. The hope is that a topical 4-OHT gel will deliver smaller, focused doses to decrease estrogen in the breast, thus lowering breast density without significant side effects.

The prospective, randomized, double-blind, placebo-controlled 4WARD trial involves an initial mammogram screening, yearlong use of the gel and follow-up visits once every three months until the participant’s next annual mammogram. USC Norris is actively recruiting for the trial, though space is limited and recruitment will close once the study reaches capacity. There are another 17 national and international sites enrolling patients. Those interested in enrolling can call (213) 509-0998 for more information.

For more information: www.uscnorriscancer.usc.edu

Related Content

Radiologists have recently taken on the role of activists and are tackling pressing issues in healthcare, including breast density

Getty Images

Feature | Women's Health | January 20, 2021 | By Fazila Seker, Ph.D.
Radiologists — who have long been professionals in the metaphorical and literal back-rooms of healthcare — have recen
Novel Coronavirus SARS-CoV-2 Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: National Institute of Allergy and Infectious Diseases, NIH

Novel Coronavirus SARS-CoV-2 Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Image courtesy of  National Institute of Allergy and Infectious Diseases (NIH)

News | Coronavirus (COVID-19) | January 15, 2021
January 15, 2021 — In one of the first studies to examine the impact of the...
A, Contrast-enhanced axial T1-weighted fat-saturated image from baseline MRI before initiation of neoadjuvant therapy shows irregular mass (arrow) in upper inner right breast corresponding to biopsy-proven carcinoma. B, Contrast-enhanced axial T1-weighted fat-saturated image from follow-up MRI performed 3 months after initiation of neoadjuvant therapy shows decrease in size of right breast cancer (arrow). C, Contrast-enhanced axial T1-weighted fat-saturated image 3 months after initiation of neoadjuvant the

A, Contrast-enhanced axial T1-weighted fat-saturated image from baseline MRI before initiation of neoadjuvant therapy shows irregular mass (arrow) in upper inner right breast corresponding to biopsy-proven carcinoma. B, Contrast-enhanced axial T1-weighted fat-saturated image from follow-up MRI performed 3 months after initiation of neoadjuvant therapy shows decrease in size of right breast cancer (arrow). C, Contrast-enhanced axial T1-weighted fat-saturated image 3 months after initiation of neoadjuvant therapy shows new mass (arrow) in upper outer left breast that was assessed as BI-RADS 4. Pathologic examination from MRI-guided core biopsy of new suspicious mass revealed benign usual ductal hyperplasia. No atypia or malignancy was identified. Image courtesy of American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

News | MRI Breast | January 15, 2021
January 15, 2021 — According to ARRS' ...
A targeted intervention providing mammograms to hospitalized Medicaid patients can help patients complete overdue breast cancer screening

Getty Images

News | Mammography | January 14, 2021
January 14, 2021 — Completing cancer screening tests, such as...
DB-I website features new educational tools and streamlined user experience to improve access to medically sourced breast density content
News | Breast Density | January 13, 2021
January 13, 2021 — DenseBreast-info.org (DB-I) invites he
This cutting-edge technology assists radiologists in the interpretation of screening mammograms and allows them to diagnose breast cancer earlier and more accurately
News | Mammography | January 12, 2021
January 12, 2021 — Therapixel announced that...
Myocarditis among recovering COVID-19 athletes less common than previously reported

Getty Images

News | Cardiac Imaging | January 11, 2021
January 11, 2021 — In a letter published in the December issue of the American Heart Association's...