Breast Cancer — Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Citation(s)
Andre F, Mazouni C, Hortobagyi GN, Pusztai L DNA arrays as predictors of efficacy of adjuvant/neoadjuvant chemotherapy in breast cancer patients: current data and issues on study design. Biochim Biophys Acta. 2006 Dec;1766(2):197-204. Epub 2006 Aug 9. Review.
Apple SK, Suthar F How do we measure a residual tumor size in histopathology (the gold standard) after neoadjuvant chemotherapy? Breast. 2006 Jun;15(3):370-6. Epub 2005 Sep 26.
Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96.
Kurosumi M Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer. Breast Cancer. 2006;13(3):254-9. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.