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Shaping the future of biomarker research in breast cancer to ensure clinical relevance

Nature Reviews Cancer volume 7, pages 309–315 (2007)Cite this article

An Erratum to this article was published on 01 May 2007

Abstract

Each year, over 200,000 people are diagnosed with breast cancer in the United States. Although the use of biomarkers has the potential to guide preventive interventions and improve survival and quality of life, there have been few successes and many disappointments. In November 2005, the National Breast Cancer Coalition Fund convened a conference aimed at developing a patient-centred, strategic approach to breast cancer biomarker research. The consumers, clinicians, researchers, industry representatives and US regulators who served on the consensus panel developed a set of principles and recommendations to guide the field and ensure that biomarker research results in clinically important applications.

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References

  1. World Health Organization. Cancer. WHO [online], (2006).

  2. American Cancer Society. Cancer Facts and Figures 2007 (American Cancer Society, Atlanta, Georgia, 2007).

  3. Mincey, B. A. Genetics and the management of women at high risk for breast cancer. Oncologist 8, 466–473 (2003).

    Article  Google Scholar 

  4. US Food and Drug Administration. FDA Clears Breast Cancer Specific Molecular Prognostic Test. FDA News [online], (2007).

  5. McShane L. M. et al. Reporting recommendations for tumor MARKer prognostic studies (REMARK). Nature Clin. Pract. Oncol. 2, 416–422 (2005).

    CAS  Google Scholar 

  6. McShane L. M. et al. REporting recommendations for tumor MARKer prognostic studies (REMARK). Brit. J. Cancer 93, 387–391 (2005).

    Article  CAS  Google Scholar 

  7. McShane L. M. et al. REporting recommendations for tumor MARKer prognostic studies (REMARK). Euro. J. Cancer 41, 1690–1696 (2005).

    Article  Google Scholar 

  8. McShane L. M. et al. Reporting recommendations for tumor marker prognostic studies. J. Clin. Oncology 23, 9067–9072 (2005).

    Article  Google Scholar 

  9. McShane L. M. et al. Reporting recommendations for tumor marker prognostic studies (REMARK). J. Natl Cancer Inst. 97, 1180–1184 (2005).

    Article  CAS  Google Scholar 

  10. Moher, D., Schulz, K. F. & Altman, D. CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285, 1987–1991 (2001).

    Article  CAS  Google Scholar 

  11. Altman, D. G. for the CONSORT Group. Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors. BMJ 330, 1056–1057 (2005).

    Article  Google Scholar 

  12. De Angelis C. et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N. Engl. J. Med. 351, 1250–1251 (2004).

    Article  Google Scholar 

  13. De Angelis C. D. et al. Is this clinical trial fully registered — a statement from the International Committee of Medical Journal Editors. N. Engl. J. Med. 352, 2436–2438 (2005).

    Article  CAS  Google Scholar 

  14. Bast, R. C. Jr, et al. 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J. Clin. Oncol. 19, 1865–1878 (2001).

    Article  Google Scholar 

  15. Wolff, A. C. et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J. Clin. Oncol. 25, 118–145 (2007).

    Article  CAS  Google Scholar 

  16. van de Vijver, M. J. et al. A gene-expression signature as a predictor of survival in breast cancer. N. Engl. J. Med. 347, 1999–2009 (2002).

    Article  CAS  Google Scholar 

  17. Paik S. et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N. Engl. J. Med. 351, 2817–2826 (2004).

    Article  CAS  Google Scholar 

  18. US Food and Drug Administration. Draft Guidance for Industry, Clinical Laboratories, and FDA Staff — In Vitro Diagnostic Multivariate Index Assays. FDA [online], (2006).

  19. Bellman, P., Havens, C., Bertolucco, Y. & Streeter, B. Facilitating physician access to medical reference information. Permanente J. 9, 27–32 (2005)

    Article  Google Scholar 

  20. The National Breast Cancer Coalition. A proposed model to prevent genetic discrimination in employment. NBCC [online], (1998).

  21. Hayes, D. F. et al. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J. Natl Cancer Inst. 88, 1456–1466 (1996).

    Article  CAS  Google Scholar 

  22. National Breast Cancer Coalition. Core Values for Breast Cancer Research. NBCC [online], (2003).

  23. National Breast Cancer Coalition. Position statement on breast cancer quality care. NBCC [online], (2003).

Download references

Acknowledgements

The National Breast Cancer Coalition Fund (NBCCF) thanks the Strategic Consensus Conference panelists, the conference planning committee and, in particular, the consumers and scientists that worked on a pre-conference Lessons Learned Research Project: D. Berry, C. Brunswick, K. Dickersin, H. Hill, M. Mayer, H. Schiff and J. Perlmutter. The Strategic Consensus Conference was made possible thanks to generous funding provided by the Regis Foundation for Breast Cancer Research, the Virginia Clinton Kelley Fund of the NBCCF, the Doris Duke Charitable Foundation and Hurricane Voices.

Author information

Authors and Affiliations

  1. M. Carolina Hinestrosa is at the National Breast Cancer Coalition Fund 1101 17th Street, NW, Suite 1300 Washington, DC 20036, USA.,

    M. Carolina Hinestrosa

  2. Key Dickersin is at the Department of Epidemiology Johns Hopkins Bloomberg School of Public Health 615 Norht Wolfe Street, Mailroom 5010, Baltimore, Maryland, 21205 USA.,

    Kay Dickersin

  3. Musa Mayer is at www.AdvancedBC.0rg, 250 West 82nd Street, Apt. 42, New York, New York, 10024, USA.,

    Musa Mayer

  4. Karin Noss is at the Virginia Breast Cancer Foundation 5004 Monument Ave, Suite 102 Richmond, Virginia 23230, USA.,

    Karin Noss

  5. Dennis Slamon is at the Division of Hematology-Oncology, Department of Medicine, UCLA Shcool of Medicine, 11-93 Louis Factor building, 10833 Le Conte Avenue, Los Angeles, California 900-5, USA.,

    Dennis Slamon

  6. George Sledge is at the Indiana University Medical Center, Indiana Cancer Pavilion, Room 473 535 Barnhill Drvive, Indianapolis, Indiana, 46202, USA.,

    George Sledge

Authors
  1. M. Carolina Hinestrosa
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  2. Kay Dickersin
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  3. Pamela Klein
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  4. Musa Mayer
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  5. Karin Noss
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  6. Dennis Slamon
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  7. George Sledge
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  8. Frances M. Visco
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Corresponding author

Correspondence to M. Carolina Hinestrosa.

Ethics declarations

Competing interests

In 2006, the National Breast Cancer Coalition Fund (NBCCF) received financial support from Genomic Health, Inc. (the manufacturer of Oncotype Dx) which amounted to less that 1% of its budget. NBCCF is a collaborator in the TAILOR clinical trial, an NCI funded study that uses Oncotype Dx.

Pamela Kelin is employed by and owns stock in Genentech, Inc.

Dennis Slamon is on Genentech's speaker's bureau and sanofi–aventis speaker's bureau.

Related links

Related links

DATABASES

National Cancer Institute

breast cancer

FURTHER INFORMATION

National Breast Cancer Coalition Fund

Strategic Consensus Conference on Biomarker Research in Breast Cancer

NCI Central Institutional Review Board Initiative

Project LEAD

Clinical Laboratory Improvement Amendments

Association of Clinical Oncologists

National Comprehensive Cancer Network

Breast Cancer Intergroup of North America

Breast International Group

National Surgical Adjuvant Breast and Bowel Project

NCI Cooperative Breast Cancer Tissue Resource

NCI's Cancer Diagnosis Program

Early Breast Cancer Trialists' Collaborative Group

Centers for Medicare and Medicaid Services

Agency for Healthcare Research and Quality

Health Insurance Portability and Accountability Act

FDA Center for Devices and Radiological Health

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Hinestrosa, M., Dickersin, K., Klein, P. et al. Shaping the future of biomarker research in breast cancer to ensure clinical relevance. Nat Rev Cancer 7, 309–315 (2007). https://doi.org/10.1038/nrc2113

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