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Table 2 Accelerating the transition from 'bench' to 'clinic' - proposed accelerated breast cancer clinical trial process

From: Randomized adjuvant trials in oncology: a necessity or time-consuming luxury?

Year 1: stage IV testing (total 1 year) i. Phase I to II testing, followed by RCT in stage IV. If effect and safety seen, start neoadjuvant testing immediately
Years 2 to 3: neoadjuvant testing (2 years) ii. Neaodjuvant setting for effectiveness: if clinical, pathology and molecular responses of a novel agent and regimen are confirmed follow with:
  iii. Randomized trials of the agents against the conventional approach, with repeated needle biopsies to correlate clinical with pathologic and molecular responses
Years 3 to 5: adjuvant testing (total 2 years) i. Large multicenter adjuvant trials with multiple international sites, involving more than 25,000 patients, to start as soon as firm responses are seen in the neoadjuvant setting
  ii. Objectives: dose response, therapy duration, long-term toxicity, and so on