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

EMR patient portal on a smartphone
News | Electronic Medical Records (EMR) | December 11, 2019
December 11, 2019 — Despite the numerous benefits associated with patients accessing their medical records, a new stu
Damage from concussion alters the way information is transmitted between the two halves of the brain, according to a new study presented today at the annual meeting of the Radiological Society of North America (RSNA).

Image courtesy of RSNA

News | Clinical Trials | December 10, 2019
December 10, 2019 — Damage from...
After receiving acupuncture treatment three days a week during the course of radiation treatment, head and neck cancer patients experienced less dry mouth, according to study results from researchers at The University of Texas MD Anderson Cancer Center

Image by Rudolf Langer from Pixabay 

News | Clinical Trials | December 06, 2019
December 6, 2019 — After receiving acupuncture treatment three days a week during the course of...
Timothy Whelan is a professor of oncology at McMaster University and a radiation oncologist at the Juravinski Cancer Centre of Hamilton Health Sciences. He holds a Canada Research Chair in Breast Cancer Research. Photo courtesy McMaster University

Timothy Whelan is a professor of oncology at McMaster University and a radiation oncologist at the Juravinski Cancer Centre of Hamilton Health Sciences. He holds a Canada Research Chair in Breast Cancer Research. Photo courtesy McMaster University. Photo courtesy of McMaster University

News | Breast Imaging | December 06, 2019
December 6, 2019 — A shorter course of higher-dose radiation treatment to part of the breast is showing promise in wo
MRI Exablate neuro helmet from INSIGHTEC

MRI Exablate neuro helmet from INSIGHTEC. Image courtesy of Ali Rezai, M.D., and RSNA.

News | Clinical Trials | December 03, 2019
December 3, 2019 — Focused ultrasound is a safe and effective way to target and open areas of the blood-brain barrier
Image by Kira Hoffmann from Pixabay  #RSNA19

Image by Kira Hoffmann from Pixabay 

News | Clinical Trials | November 30, 2019
November 30, 2019 — Researchers are trying to identify injury patterns and predict future outcomes for victims of gun
#RSNA19 GE Healthcare introduced Serena Bright, the healthcare industry’s first contrast-enhanced mammography solution for biopsy
News | Mammography | November 30, 2019
November 30, 2019 — To help empower clinicians and patients in their fight against...
This bar graph shows breast cancer presentation by screening interval #RSNA19

This bar graph shows breast cancer presentation by screening interval. Image courtesy of study author and RSNA

News | Breast Imaging | November 28, 2019
November 28, 2019 — Cancers found in patients undergoing annual...