Statistical Issues and Challenges

  • Meredith M. Regan
Part of the Cancer Treatment and Research book series (CTAR, volume 151)

Adjuvant therapy clinical trials for early breast cancer have historically been treatment focused—for example assessing the role of chemotherapy, tamoxifen, ovarian ablation—rather than patient-population focused. Therapeutic effects of adjuvant therapies for early breast cancer have been assessed “across the board” and implemented using the principle that if a treatment is effective “on average” then it is effective “for all patients.” There is new effort to tailor early breast cancer clinical trials to populations of patients who might have the best chance to benefit from the therapies being studied. For example, estrogen receptor (ER) and progesterone receptor (PgR) are the most important factors used today to tailor adjuvant therapies [1, 2], and recent pivotal trials of adjuvant trastuzumab (Herceptin) demonstrated its benefit among patients whose tumors overexpressed HER2/neu [3–5]. Exploration and improved understanding of the biological basis for predicting response to available adjuvant therapies is essential to enhance patient care.


Early Breast Cancer Recurrence Score High Recurrence Score Landmark Clinical Trial Intermediate Recurrence Score 
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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.IBCSG Statistical Center, Department of Biostatistics and Computational BiologyDana-Farber Cancer Institute and Harvard Medical SchoolBostonUSA

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