Are we HER-ting for innovation in neoadjuvant breast cancer trial design?
| Autor: | Natasa Snoj, Philippe L. Bedard, Fatima Cardoso, Martine Piccart, Evandro de Azambuja |
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| Rok vydání: | 2009 |
| Předmět: |
Gynecology
Research design Clinical Trials as Topic medicine.medical_specialty business.industry medicine.medical_treatment Breast Neoplasms -- drug therapy Breast Neoplasms Translational research Review Sciences bio-médicales et agricoles medicine.disease Neoadjuvant Therapy Clinical Practice Breast cancer Drug development Research Design medicine Humans Medical physics business Human Epidermal Growth Factor Receptor 2 Neoadjuvant therapy |
| Zdroj: | Breast cancer research, 11 (1 Breast Cancer Research : BCR |
| ISSN: | 1465-542X |
| DOI: | 10.1186/bcr2209 |
| Popis: | Through the use of surrogate markers of efficacy, neoadjuvant studies may facilitate the implementation of new treatments into clinical practice. However, disease-free survival is the current standard outcome endpoint for registration of a novel treatment. The coupling of smaller neoadjuvant 'proof of principle' studies with larger adjuvant registration trials offers the promise of speeding up the time to market of new therapies. Clever new designs, such as the 'biological window' and 'learn on the way', can provide valuable insight regarding mechanisms of action and resistance of these novel drugs by identifying patients who are most likely to respond to a novel therapy early in the drug development process. Using the ongoing neoadjuvant trials with HER2 (human epidermal growth factor receptor 2)-directed therapy as a paradigm, this article discusses recent innovations in study design and the challenges of conducting translational research in the neoadjuvant setting. Journal Article Review SCOPUS: re.j info:eu-repo/semantics/published |
| Databáze: | OpenAIRE |
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