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Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer
Joseph A Sparano1, Robert J Gray1, Peter M Ravdin1
1From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); University of Texas, San Antonio (P.M.R.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Medical Center, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O., J.A.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); the National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and the University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and the University of Hawaii Cancer Center, Honolulu (J.L.B.).
Clinical risk assessment adds prognostic value to the 21-gene recurrence score for breast cancer, helping identify premenopausal women who may benefit from tailored therapies. This improves treatment decisions for recurrence risk.
Area of Science:
- Oncology
- Genomics
- Clinical Trials
Background:
- Adjuvant chemotherapy decisions for breast cancer rely on clinicopathological factors and a 21-gene recurrence score.
- The added prognostic value of clinical risk assessment to the 21-gene recurrence score is not well-established.
Purpose of the Study:
- To determine if clinical risk of breast cancer recurrence provides additional prognostic information beyond the 21-gene recurrence score.
- To evaluate the combined prognostic utility of clinical risk and the 21-gene recurrence score in guiding treatment decisions.
Main Methods:
- A prospective trial of 9427 women with hormone-receptor-positive, HER2-negative, node-negative breast cancer.
- Clinical risk (low/high) based on tumor size and histologic grade, alongside a 21-gene recurrence assay.
- Cox proportional-hazards models used to assess hazard ratios for distant recurrence.
Main Results:
- Clinical risk was prognostic for distant recurrence in women with intermediate (11-25) and high (26-100) 21-gene recurrence scores.
- In premenopausal women ≤50 years receiving endocrine therapy alone, distant recurrence rates varied significantly based on combined clinical and 21-gene recurrence scores.
- High clinical risk with intermediate or high recurrence scores indicated higher recurrence rates, particularly with endocrine therapy alone.
Conclusions:
- Clinical-risk stratification offers prognostic information that complements the 21-gene recurrence score.
- This combined approach can identify premenopausal women who may benefit from more intensive or tailored therapies.
- The findings support integrating clinical risk assessment into treatment strategies for early-stage breast cancer.
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