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Table 1 Doses used in the breast cancer PAINT first-in-human investigation

From: Breast cancer PAINT: a first-in-human, dose-escalation study to determine the safety of Plasma Adjuvant INtra-operative Treatment in breast cancer patients

Dose Level #

Dose

Group

Dose Level − 1

2 min per 7 mm2

Group C – if 1 DLT out of 3 or 2 DLTs out of 6 (30 min max)

Dose Level 1 (starting dose)

3 min per 7 mm2

Group C, Cohort 1 (30 min max)

Dose Level 2

4 min per 7 mm2

Group C, Cohort 2 (30 min max)

Dose Level 3

5 min per 7 mm2

Group C, Cohort 3 (30 min max)

Group A (15 min max)

Group B (15 min max)

  1. Three dose levels will be assessed for DLTs. If DLT toxicity occurs in the initial cohort for group C, then a provision has been added for a fourth lower dose to be explored with an expanded patient cohort (in bold text)