Panel in eCRF | Data recorded |
---|---|
Informed consent | Date |
I/E criteria | Yes; not |
Demographic data | Age at inclusion; Menstrual State |
Comorbidities | If yes: specify |
Cancer Histology and Receptors, SLN OSNA | Tumour grade; Tumour size (maximum diameter); P53 (%); Ki67 (%); Lymphovascular infiltration; Ductal Ca in situ; % Estrogenic receptors; % Progesterone receptors; HER2 receptor status; OSNA TTL of SLN |
Previous medication (Adjuvant therapy) | Drug; Start date; Stop date |
Type of surgery | Tumour surgery; date; Margins |
Randomization | Treatment randomly allocated; Randomization date |
Radiotherapy intervention | Patient completed the allocated treatment (If no: main reason); Start date; End date; Treatment gaps (If yes, reason); Dose per volume (Mean; Median; D95; D5; Volume) in the breast, tumour bed, supraclavicular and axillary levels I-III, and Internal mammary chain |
Co-medication | Drug; Start date; Stop date |
Survival and disease recurrence | Date of follow-up visit (If not performed, reason); Local recurrence; Regional recurrence (If yes: nodal level); Distant recurrence (If yes: organ); Vital status (if dead: date and cause) |
Image evaluation of local recurrence | Technique; Local recurrence (if yes: Maximum diameter) |
Physical examinationa | Palpable breast tumour (if yes: size, skin infiltration, inflammatory carcinoma, satellite lesions); Palpable axillary nodes (if yes: size); Palpable supraclavicular nodes (if yes: size); Node staging |
Acute and chronic toxicity | CTCAE term; Grade; Start date; Stop date; Status (recovered w/o sequels; death) |