Sponsor
University of California, San Francisco
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT02620852
Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis."
This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive.
For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines.
If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.
This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive.
For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines.
If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.
Intervention
Complete a health questionnaire, Provide a saliva sample for genetic testing, Screening advice based on a basic risk assessment, Screening advice based on a comprehensive risk assessment
Condition
Breast Cancer Screening, Breast Carcinoma in Situ, Breast Cancer
Investigators
Laura Esserman, MD, MBA, Hoda Anton-Culver, PhD, Lisa Madlensky, PhD, Barbara Parker, MD, Isabella Cabaleiro, Rachael Lancaster, MD, Yiwey Shieh, MD, Alexander Borowsky, MD, Stacey Ingram, MEd, Laura van 't Veer, PhD, Olufunmilayo Olopade, MD, Antonia Petruse, BA, Hannah Park, PhD, Arash Naeim, MD, PhD, Skye Stewart, MS, Andrea LaCroix, PhD, Michael Plaza, MD, Ilona Siljander, Brenda Gonzales, Sheri Hartman, PhD, Agustin Garcia, MD, Eileen Mederos, RN