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Statistical Issues and Challenges

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Adjuvant Therapy for Breast Cancer

Part of the book series: Cancer Treatment and Research ((CTAR,volume 151))

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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.

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Author information

Authors and Affiliations

  1. IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA

    Meredith M. Regan ScD

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  1. Meredith M. Regan ScD
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Correspondence to Meredith M. Regan ScD .

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Editors and Affiliations

  1. Inselspital, Univ. Bern, Bern, 3010, Switzerland

    Monica Castiglione

  2. Inst. Jules Bordet, Universite Libre Bruxelles, Bd. de Waterloo 125, Bruxelles, 1000, Belgium

    Martine J. Piccart

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Regan, M.M. (2009). Statistical Issues and Challenges. In: Castiglione, M., Piccart, M. (eds) Adjuvant Therapy for Breast Cancer. Cancer Treatment and Research, vol 151. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-75115-3_6

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  • DOI: https://doi.org/10.1007/978-0-387-75115-3_6

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  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-387-75114-6

  • Online ISBN: 978-0-387-75115-3

  • eBook Packages: MedicineMedicine (R0)

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