Principles of Clinical Trials

  • Ludwig Breast Cancer Study Group
Part of the Recent Results in Cancer Research / Fortschritte der Krebsforschung / Progrès dans les recherches sur le cancer book series (RECENTCANCER, volume 71)


Proper design and conduct of a clinical trial requires the consideration of a set of principles. These principles include the collaborative effort, consideration of both a medical and a statistical plan, and development of a data network. The Ludwig Breast Cancer Study Group with international participants has been formed according to these principles. This represents an approach to clinical trials which is designed to maximize the scientific pay-off. The goal is to determine the optimal treatment for every identifiable prognostic subgroup of patients.


Breast Cancer Advanced Breast Cancer Collaborative Effort Statistical Plan Operable Breast Cancer 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Ahmann, D. L., O’Connell, M. J., Hahn, R. G., Bisel, H. F., Lee, R. A., Edmonson, J. H.: An evaluation of early or delayed adjuvant chemotherapy in premenopausal patients with advanced breast cancer undergoing oophorectomy. N. Engl. J. Med. 297, 356–360 (1977)PubMedCrossRefGoogle Scholar
  2. Bonadonna, G., Rossi, A., Valagussa, P., Banfi, A., Veronesi, U.: The CMF program for operable breast cancer with positive axillary nodes. Cancer 39, 2904–2915 (1977)PubMedCrossRefGoogle Scholar
  3. Brunner, K. W., Sonntag, R. W., Alberto, P., Senn, H. J., Martz, G., Obrecht, P., Maurice, P.: Combined chemo- and hormonal therapy in advanced breast cancer. Cancer 39, 2923–2933 (1977)PubMedCrossRefGoogle Scholar
  4. Cole, M. P.: Suppression of ovarian function in primary breast cancer. In: Prognostic factors in breast cancer. Forrest, A. P. M., Kunkler, E. S. (eds.), pp. 146–156. Edinburgh, London: Livingston 1968Google Scholar
  5. Fisher, B., Slack, N., Katrych, D. L., Wolmar, K. N.: Ten year follow-up of breast cancer patients in a cooperative clinical trial evaluating surgical adjuvant chemotherapy. Surg. Gynecol. Obstet. 140, 528–534 (1975)PubMedGoogle Scholar
  6. Fisher, B., Glass, A., Redmond, C., Fisher, E. R., Barton, B., Such, E., Carbone, P., Economou, S., Foster, R., Frelick, R., Lerner, H., Levitt, M., Margolese, R., MacFarlane, J., Plotkin, D., Shibata, H., Volk, H. (and other cooperating investigators): L-Phenylalanine Mustard (L-PAM) in the management of primary breast cancer. Cancer 39, 2883–2903 (1977)PubMedCrossRefGoogle Scholar
  7. Freiman, J. A., Chalmers, T. C., Smith, H., Jr., Kubler, R.: Importance of beta type error and sample size in the randomized control trial. N. Engl. J. Med. 299, 690–694 (1978)PubMedCrossRefGoogle Scholar
  8. Meakin, J. W., Allt, W. E. C., Beale, F. A., Brown, T. C., Bush, R. S., Clark, P. M., Fitzpatrick, P. J., Hawkins, N. V., Jenkin, R. D. T., Pringle, J. F., Rider, W. D.: Ovarian irradiation and prednisone following surgery for carcinoma of the breast. In: Adjuvant therapy of cancer. Salmon, S. E., Jones, S. E. (eds.), pp. 95–99. Amsterdam: Elsevier/North Holland, Biomed. Press 1977Google Scholar
  9. Nissen-Meyer, R.: The role of prophylactic castration in the therapy of human mammary carcinoma. Eur. J. Cancer 3, 395–403 (1967)PubMedCrossRefGoogle Scholar
  10. Nissen-Meyer, R., Kjellgren, K., Malmio, K., Mansson, B., Norin, T.: Results with one short course with cyclophosphamide after mastectomy for breast cancer. Cancer 4, 2088–2098 (1978)CrossRefGoogle Scholar
  11. Ravdin, R. G., Lewinson, E. F., Slack, N. H.: Results of a clinical trial concerning the worth of prophylactic oophorectomy for breast carcinoma. Surg. Gynecol. Obstet. 141, 1055–1064 (1970)Google Scholar
  12. Stjernswärd, J.: Adjuvant radiotherapy trials in breast cancer. Cancer 39, 2846–2867 (1977)PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1980

Authors and Affiliations

  • Ludwig Breast Cancer Study Group
    • 1
  1. 1.Ludwig Institut für Krebsforschung, InselspitalBernSwitzerland

Personalised recommendations