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

Christopher Comstock, M.D., ECOG-ACRIN Cancer Research Group study published in JAMA builds evidence for use of abbreviated MRI in women with dense breasts

Christopher Comstock, M.D., (Memorial Sloan Kettering Cancer Center) is the lead author of a paper in JAMA that reports that abbreviated breast MRI detected significantly more (almost 2 and a half times as many) breast cancers than digital breast tomosynthesis (3-D mammography) in average-risk women with dense breasts. Photo courtesy of Memorial Sloan Kettering Cancer Center

News | Breast Imaging | February 26, 2020
February 26, 2020 — According to a study
Women 75-plus May Not Benefit from Breast Cancer Screening
News | Mammography | February 25, 2020
February 25, 2020 — According to newly published research in an article titled...
An example of the MRI scans showing long-term and short-term survival indications. #MRI

An example of the MRI scans showing long-term and short-term survival indications. Image courtesy of Case Western Reserve University

News | Magnetic Resonance Imaging (MRI) | February 21, 2020
February 21, 2020 — ...
A cutting-edge magnet resonance imaging (MRI) technique to detect iron deposits in different brain regions can track declines in thinking, memory and movement in people with Parkinson's disease #Parkinsons #MRI

Summary steps of the processing pipeline for QSM reconstruction (phase pre-processing and map estimation) and whole brain/regional analysis. ANTs, advanced normalisation tools; MP-RAGE, magnetisation-prepared, 3D, rapid, gradient-echo; MSDI, multi-scale dipole inversion; QSM, quantitative susceptibility mapping; ROI, region of interest; SWI, susceptibility weighted imaging.

News | Magnetic Resonance Imaging (MRI) | February 21, 2020
February 21, 2020 — A cutting-edge...
Recognized as the “Pulitzer Prize of the business press,” the Jesse H. Neal Award finalists are selected for exhibiting journalistic enterprise, service to the industry and editorial craftsmanship
News | Radiology Business | February 19, 2020
February 19, 2020 — Connectiv, a division of The Software and Information Industry Association (SIIA), has announced
Arizona State University researchers (in collaboration with Banner MD Anderson Cancer Center) have discovered a biocompatible cost-effective hydrogel that can be used to monitor therapeutic doses of ionizing radiation by becoming more pink with increasing radiation exposure

Arizona State University researchers (in collaboration with Banner MD Anderson Cancer Center) have discovered a biocompatible cost-effective hydrogel that can be used to monitor therapeutic doses of ionizing radiation by becoming more pink with increasing radiation exposure. This picture shows a circle of hydrogel that was irradiated on the left half, which is slightly pink; whereas the right half of the gel is not irradiated and remains colorless.

News | Radiation Therapy | February 18, 2020
February 18, 2020 — More than half of all cancer patients undergo radiation therapy and the dose is critical.
Mammograms of a 49-year-old woman with invasive lobular carcinoma on the right-side breast

Mammograms of a 49-year-old woman with invasive lobular carcinoma on the right-side breast. A small mass with micro-calcifications on the right-side breast was detected correctly by AI with an abnormality score of 96%. This case was recalled by 7 out of 14 radiologists (4 breast radiologists and 3 general radiologists) initially (without AI) and all 14 radiologists recalled this case correctly with the assistance of AI.

News | Artificial Intelligence | February 11, 2020
February 11, 2020 — A new study, published in...
Accuray TomoTherapy total body irradiation
News | Radiation Therapy | February 07, 2020
February 7, 2020 — Accuray Incorporated announced that two new studies demonstrate the benefits of the ...
Sponsored Content | Videos | Artificial Intelligence | February 06, 2020
ProFound AI is an FDA-cleared artificial intelligence (AI) system for reading 3-D breast tomosynthesis images.