Identify Molecular Predictors of Risk to Objectively Validate Evolution of DCIS (IMPROVE DCIS)
Abstract
There is a need to learn which normal cells become cancerous. An ideal setting to study how cells turn into cancer is ductal carcinoma in situ (DCIS), a pre-cancerous condition where some lesions advance to invasive breast cancer (IBC), while most do not. Current guidelines state that all DCIS should be treated with surgery/radiation, which results in overtreatment for women with DCIS who will never get IBC. Our team has enrolled almost 1,000 women in the U.S. to the COMET study, which studies whether women with low-risk DCIS can safely use an active monitoring (AM) approach rather than surgery. We have also finished the ICICLE study in the U.K. that recruited 3,035 women with DCIS to look at certain genes and their roles in development of DCIS and possible advancement to IBC. Based on other studies, we also developed molecular risk groups to identify DCIS that may lead to IBC. Additional data generated by the proposed study will be combined with data from the previous studies to improve the existing risk groups, and to develop a more complete way to predict risk of IBC. The study will directly address three challenges. (1) Conquer the problems of overdiagnosis (diagnosing an illness that may never cause a problem) and overtreatment (unnecessary treatment of an illness): Identifying more factors that can be linked to IBC will help reduce overdiagnosis and overtreatment of DCIS. (2) Distinguish deadly from non-deadly breast cancers: The study will determine whether factors in DCIS cells and tissue can be examined to accurately predict which women with DCIS may develop IBC versus those women who will not. (3) Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival: Data and review of samples from the proposed study will be combined with the two previous studies to help us learn whether AM can be safely used to treat low-risk DCIS, rather than surgery and radiation. The study aims to help women diagnosed with different kinds of DCIS by providing more information about their potential treatment options. There are no anticipated risks to women who provided tissue samples in the previous studies. It is expected that this study will assist researchers to better understand DCIS, which could help provide more useful treatment information for women diagnosed with DCIS in the future. The study team includes three consumer advocates who are closely linked to local and national breast cancer organizations and advocacy communities (U.K./U.S.). They will use their relationships with advocacy and community-based organizations to inform our work, increase the impact of patient participation in clinical research; and their different ethnic backgrounds will ensure that women with DCIS from underrepresented groups are encouraged to participate. The expected clinical impact of this study on the Breast Cancer Research Program (BCRP) mission of ending breast cancer will help reduce overdiagnosis and overtreatment of DCIS by learning whether some women with low-risk DCIS can safely use AM instead of surgery and radiation.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311031
Entities
People
- Robert West
Organizations
- Stanford University
- United States Army