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

Table 2 Study calendar

Required Investigations	Screening	Day of Surgery and NTP treatment	Post-op Follow-Up #1¹	Post-op Follow-Up #2	Post-op Follow-Up #3	End of study Follow-up
Window	Within 28 days of treatment	-	Day 2–3 post-op	Day 7 post-op; +/- 3 days	Day 30; +/- 7 days	Day 90; +/- 30 days
Demographics	X
History and Physical Exam	X	X	X	X	X	X
Quality of life questionnaire	X²		X	X	X	X
Hematology, Biochemistry	X				X	X
NTP administration and Tissue collection		X
Ultrasound	X				X
Image collection	X³			X	X	X
ECG	X
Concomitant medication review	X	Continuously
Adverse events	Continuously

¹ Post-op follow-up #1 can be conducted by phone. If so, only ECOG performance status and quality of life questionnaires will be mandatory
² Not applicable for group A
³ Image collection for group C patients only

ISSN: 1471-2407