Advancing hormone therapy for endometrial cancer

Active Project Grant Awarded Last action

Award ID
P01CA278735
Recipient
Awarding agency
Obligated
$5,291,136

Award facts

Assistance listing
93.393 Cancer Cause and Prevention Research
Completion date 25% complete
Place of performance
Albuquerque, NM 87131, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Overall advancing hormone therapy for endometrial cancer uterine endometrial cancer (EC) is the only cancer with significantly worse outcomes today compared to 50 years ago. There is an urgent need to improve clinical management of EC patients and patients with pre- cancerous atypical endometrial hyperplasia (AEH) through the development of safer and more effective prevention and treatment strategies. This multi-institutional P01 application seeks to improve outcomes for EC- AEH patients by identifying improved strategies to: 1) prevent the transition of AEH to EC, 2) prevent the progression of EC after initial treatment, and 3) prevent treatment-associated breast cancer. First used in the 1970S, progestins (synthetic compounds that target progesterone receptor) are still the only FDA-approved pharmacological agent for early-stage/low-grade EC treatment, representing the majority of EC tumors. Despite being a relatively safe and effective clinical tool, progestin use is very limited. We propose that progestins are under-utilized for three reasons: 1) despite FDA approval of >20 progestins for contraception and hormone replacement therapy, they have not been systematically evaluated for prevention and treatment of EC-AEH, and as a result the most effective progestin is not known; 2) there are no clinical or molecular biomarkers that predict progestin efficacy much less the use of specific progestins; and 3) the safety of long-term progestin use has been called into question by multiple clinical studies linking progestin use to increased breast cancer risk. The ideal progestin would be at least or more effective than the current standard of care in EC-AEH, but with an improved profile for cancer initiation and progression in the breast. Accordingly, the goals of this collaborative project are to identify the ideal progestin(S) for EC-AEH prevention and treatment, and to use them more effectively by understanding their mechanism and identifying patients who will benefit from their use. To achieve our goals, we have assembled an exceptional team of investigators with extensive expertise in endometrial cancer, breast cancer, and steroid hormone signaling to systematically evaluate progestin efficacy on a phenotypic (project 1), molecular (project 2), and clinical (project 4) level, while counterbalancing efficacy with the potential for unwanted effects in the breast (project 3). To aid in the success of these projects, the administrative core will provide critical organizational and administrative support to all projects, the biospecimen core will provide important sample and pathology services to all projects, and the data analysis core will provide biostatistics and bioinformatics support essential for all projects. Our understanding of the mechanism of action and the effectiveness of progestins lags far behind their extensive clinical use in women. By working as a collaborative team, we hope to establish a new paradigm for prevention and treatment of EC-AEH by identifying the optimal progestin(S) to be used in clinical practice, as well as which patients are most likely to derive benefit. The four projects and three cores are highly synergistic, supporting an in-depth analysis of progestin action and clinical effectiveness within the same program.

Transactions

Action Obligated Date
Amendment $2,489,255
Original award $2,801,881

Subawards

Subrecipient Amount Awarded
Rector & Visitors Of The University Of Virginia Dr. Duska will serve as a co-Investigator for Project 4. She will coordinate the Virginia portion of the surgical window clinical trial, including trial startup… $86,209
University Of Kansas Medical Center Research Institute, Inc. SCOPE OF WORK University of Kansas - Project 3 Dr. Hagan will serve as the Leader of Project 3. She will be responsible for project oversight, the supervision… $454,207
The University Of Iowa Dr. Thiel will serve as the leader of Project 1and will be responsible for project oversight, the supervision of lab personnel to carry out each of Project… $500,265
University Of California, San Diego University of California San Diego – Biospecimen Core Dr. Molino will serve as a co-Investigator on the Biospecimen Core. He will be responsible for… $14,672
University Of Utah Drs. Gertz and Maurer will serve as co-Investigators on Project 4. Dr. Gertz will contribute to biomarker assessment and discovery by overseeing the bulk… $905,566
Sanford Research Dr. De La Puente will serve as a co-Investigator on Project 1 and will advise on in vitro experiments in Aim 1, including experimental design, data analysis and… $12,649

Quick answers

Who received award P01CA278735?

P01CA278735 was awarded to University Of New Mexico by National Cancer Institute (National Institutes of Health) on August 8, 2025.

How much is award P01CA278735 worth?

$5,291,136 has been obligated on P01CA278735.

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