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

A recent study earlier this year in the journal Nature, which included researchers from Google Health London, demonstrated that artificial intelligence (AI) technology outperformed radiologists in diagnosing breast cancer on mammograms
Feature | Breast Imaging | April 06, 2020 | By Samir Parikh
A recent study earlier this year in the journal Nature,
Feature | Breast Density | April 03, 2020 | By Dayna Williams M.D., Shivani Chaudhry, M.D., and Laurie R. Margolies, M.D.
Breast cancer is the most common cance
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 New studies use SIRD model to forecast COVID-19 spread; examine patient CT scans to correlate clinical features with mortality

Fig 1. A sample scoring on CT images of a 63-year-old woman from mortality group demonstrated a total score of 63. It was calculated as: for upper zone (A), 3 (consolidation) × 3 (50–75% distribution) × 2 (both right and left lungs) + 2 (ground glass opacity) ×1 (< 25% distribution) × 2 (both right and left lungs); for middle zone (B), 3 (consolidation) × 2 (25–50% distribution) × 2 (both right and left lungs) + 2 (ground glass opacity) × 2 (25–50% distribution) × 2 (both right and left lungs); for lower zone (C), 3 (consolidation) × (2 (25–50% distribution of the right lung) + 3 (50–75% distribution of the left lung)) + 2 (ground glass opacity) × (2 (25–50% distribution of the right lung) + 1 (< 25% distribution of the left lung)) Yuan et al, 2020 (CC BY 4.0)

News | Coronavirus (COVID-19) | April 01, 2020
April 1, 2020 — A new study, ...
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Mammography | March 25, 2020
March 25, 2020 — The...
The 2020 Society of Breast Imaging/American College of Radiology (SBI/ACR) annual symposium has been cancelled, and the event rescheduled for April 8-11, 2020, in Savannah, Ga. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SBI20
News | Society of Breast Imaging (SBI) | March 16, 2020
March 16, 2020 — The 2020 Society of Breast Imaging/American College of Radiology (...
A University of Colorado Cancer Center study published in the Journal of the National Cancer Institute shows an important predictor of PET-CT use

Rustain Morgan, M.D., and colleagues show racial/ethnic disparities in use of important imaging during lung cancer diagnosis. Photo courtesy of University of Colorado Cancer Center

News | PET-CT | March 12, 2020
March 12, 2020 — The use of PET-CT
DBT, sometimes called 3-D mammography, emerged in the last decade as a powerful tool for breast cancer screening

Images in a 57-year-old woman noted to have "good prognosis" invasive cancer detected at digital breast tomosynthesis (DBT) screening. (a) Craniocaudal view of the left breast obtained with the two-dimensional digital mammography (DM) portion of the DM/DBT screening study demonstrates a subtle area of distortion in the medial left breast. (b) Single-slice image from the left craniocaudal DBT portion of the screening study shows an area of bridging distortion (circle). (c) Electronically enlarged image of the area of concern seen on the left craniocaudal view in a single DBT slice as shown in b. (d) Targeted US scan demonstrates two small adjacent irregular solid masses. US-guided core biopsy yielded an invasive carcinoma of the tubular subtype that was estrogen receptor positive, progesterone receptor positive, and human epidermal growth factor receptor 2 negative. The results of the sentinel node biopsy were negative. Image courtesy of the Radiological Society of North America

News | Breast Imaging | March 11, 2020
March 11, 2020 — A new study published in the journal ...
SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories

Example: SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories ((a), fatty; (b), scattered; (c), heterogeneously dense; (d), extremely dense). Note the quantitative scale indicating that absolute measurements are obtained. Image courtesy of MDPI

News | Breast Imaging | March 10, 2020
March 10, 2020 — ...
The study concludes that a combination of Artificial Intelligence algorithms and the interpretations of radiologists could, in the U.S. alone, result in a half million women not having to undergo unnecessary diagnostic tests every year

Researchers who participated in the DM (digital mammography) DREAM Challenge.

News | Mammography | March 07, 2020
March 7, 2020 — The stu...