A woman can be defined as at-increased-risk of breast cancer by several different parameters.
- Personal prior breast cancer history
- Patients with prior thoracic radiation therapy under 30
- Women with LCIS, DCIS or atypical hyperplasia
- Pedigree suggestive of hereditary cancer syndrome
- Women with lifetime risk >20% (based on family history)
- Women with 5 year risk ≥ 1.66%
BREVAGenplus can help you identify a woman at increased risk as defined by her 5 year risk score.
Several key professional societies including the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network® (NCCN®), the American Congress of Obstetricians and Gynecologists (ACOG) as well as the US Preventative Services Task Force (USPSTF) have come out with recommendations regarding the engaged, informed decision-making process between a woman that has been identified as high risk according to her 5 year risk score and her clinician regarding the potential benefits of risk reducing medications(1,2,3,4).
Scientific and Clinical Evidence
These recommendations have expanded over the past 2 decades, since the FDA first approved Tamoxifen for use in breast cancer prevention for women at high risk of breast cancer (as defined by her 5 year risk ≥ 1.66%)5. In the most current recommendations, there are now 30+ manuscripts that have summarized key findings from multiple placebo controlled trials of Tamoxifen, Raloxifene and Aromatase inhibitors as well as multiple comparative trials. Significant and compelling data suggests that up to 50% of breast cancer incidence can be prevented with Tamoxifen6. Raloxafene, while slightly less efficacious compared to Tamoxifen, had fewer side-effects7. Furthermore, Aromatase Inhibitors among postmenopausal women have shown a 65% decrease in invasive breast cancer compared to placebo8.
Clinical investigations are still on-going to assess long term outcomes from many of these clinical trials however there is overwhelming evidence suggesting that breast cancer can be prevented within a population of women identified at increased risk by their 5 year risk score.
While there are a handful of risk assessment modules available to assess a woman’s 5 year risk of breast cancer(9-11), BREVAGenplus is the only one that integrates a woman’s polygenic risk score to better stratify your at-risk patient.
- BREVAGenplus™ provides information about breast cancer risk over a 5 year period; it does not diagnose breast cancer
- BREVAGenplus is validated in African American, Caucasian, and Hispanic women age 35 years or older
- The risk estimate used in this test does not take into account several other breast cancer risk factors, such as an extensive family history of breast and ovarian cancer and thus does not provide a lifetime risk score
- This test is used for clinical purposes
* BREVAGenplus is not applicable to women who are already at high risk of breast cancer including those that have a personal or extensive family history of breast and/or ovarian cancer, LCIS, DCIS, AH or have thoracic RT under 30y. Any women with these risk factors are already at increased risk of breast cancer and should be screened and followed as such.
1. Final Update Summary: Breast Cancer: Medications for Risk Reduction. U.S. Preventive Services Task Force. September 2016.
https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-medications-for-risk-reduction?ds=1&s=breast cancer risk
2. Visvanathan K1, Hurley P, Bantug E, Brown P, Col NF, Cuzick J Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2013 Aug 10;31(23):2942-62.
3. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Breast Cancer Risk Reduction, NCCN Evidence Blocks Version 1.2017. http://www.nccn.org, 2016.
4. Breast cancer risk assessment and screening in average-risk women. Practice Bulletin No. 179. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;130:e1–16.
5. Lippman S., Brown, P. Tamoxifen Prevention of Breast Cancer: an Instance of the Fingerpost. J Natl Cancer Inst (1999) 91 (21): 1809-1819.
6. Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998;90:1371- 1388.
7. Vogel VG, Costantino JP, Wickerham DL, et al. Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer. Cancer Prev Res (Phila) 2010;3:696-706.
8. Goss PE, Ingle JN, Ales-Martinez JE, et al. Exemestane for breast- cancer prevention in postmenopausal women. N Engl J Med 2011;364:2381-2391.
9. Chen J, Pee D, Ayyagari R, Graubard B, Schairer C, Byrne C, et al. Projecting absolute invasive breast cancer risk in white women with a model that includes mammographic density. J Natl Cancer Inst. 2006;98:1215-26.
10. Tice JA, Cummings SR, Smith-Bindman R, Ichikawa L, Barlow WE, Kerlikowske K. Using clinical factors and mammographic breast density to estimate breast cancer risk: development and validation of a new predictive model. Ann Intern Med. 2008;148:337-47
11. Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Shairer C, Mulvihill JJ: Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 81(24):1879-86, 1989.