Table 3 Final core outcome set for locoregional treatment outcome reporting in breast cancer neoadjuvant systemic therapy trials
No | Core outcome set domain |
|---|---|
1 | The type of breast and axillary surgery planned before starting NST |
2 | The proportion of patients who did not have surgery after NST due to disease progression, treatment toxicities or other comorbidities |
3 | The number/proportion of patients with a complete response to NST not having surgery to the breast and/or axilla, and how response was assessed |
4 | How response to NST in the breast and axilla was assessed |
5 | Type of initial breast and axillary surgery performed after NST |
6 | Proportion of patients with involved margins after initial and final surgery, and number of procedures required (and recorded definition of clear margins at atrial levela) |
7 | Total number of excised and involved axillary lymph nodes, with extent of involvement |
8 | Further axillary treatment in patients with ypN+ disease after sentinel node biopsy/targeted axillary dissection (SLNB/TAD) |
9 | Proportion of patients in whom breast and/or axillary surgery was downstaged |
10 | The proportion of patients having radiation therapy |
11 | Indications for radiation therapy at trial levela (recorded in protocol and reported) |
12 | Details of breast/chest wall and nodal targets |
13 | Details of dose and fractionation to breast/chest wall and nodal areas |
14 | Receipt of boost; indications for boost (at trial levela) |
15 | Morbidity of locoregional treatments (short and long term as defined in protocol) |
