Table 1.
Patient characteristics.
| Conventional chemotherapy n = 60 (%) | High-dose chemotherapy n = 62 (%) | All randomized patients n = 122 (%) | |
|---|---|---|---|
| Median age (IQR) | 42 (37–51) | 43 (36–50) | 43 (37–51) |
| Menopausal statusa | |||
| Pre | 41 (68%) | 43 (70%) | 84 (69%) |
| Peri | 5 (8%) | 6 (10%) | 11 (9%) |
| Post | 14 (23%) | 12 (20%) | 26 (21%) |
| NA | 0 | 1 | 1 |
| Size (T) | |||
| 1 | 4 (7%) | 4 (6%) | 8 (7%) |
| 2 | 44 (73%) | 47 (76%) | 91 (75%) |
| 3 | 10 (17%) | 10 (16%) | 20 (16%) |
| 4 | 2 (3%) | 1 (2%) | 3 (2%) |
| Nodal status (N) | |||
| 0 | 26 (43%) | 21 (34%) | 47 (39%) |
| 1 | 20 (33%) | 26 (42%) | 46 (38%) |
| 2 | 4 (7%) | 5 (8%) | 9 (7%) |
| 3 | 10 (17%) | 10 (16%) | 20 (16%) |
| Stage | |||
| II | 42 (70%) | 44 (71%) | 86 (70%) |
| III | 18 (30%) | 17 (27%) | 35 (29%) |
| IV | 0 (0%) | 1 (2%) | 1 (1%) |
| Grade | |||
| Well differentiated | 0 (0%) | 1 (2%) | 1 (1%) |
| Moderately differentiated | 3 (8%) | 10 (20%) | 13 (15%) |
| Poorly differentiated | 34 (92%) | 38 (78%) | 72 (84%) |
| NA | 23 | 13 | 36 |
| Copy number profile | |||
| BRCA1-like | 51 (96%) | 57 (98%) | 108 (97%) |
| Sporadicb | 2 (4%) | 1 (2%) | 3 (3%) |
| NAb | 7 | 4 | 11 |
| Germline mutation | |||
| BRCA1 | 12 (27%) | 12 (25%) | 24 (26%) |
| BRCA2 | 0 (0%) | 2 (4%) | 2 (2%) |
| PALB2 | 1 (2%) | 0 (0%) | 1 (1%) |
| Noc | 32 (71%) | 34 (71%) | 66 (71%) |
| NAd | 15 | 14 | 29 |
| BRCA1 promoter hypermethylation | |||
| Yes | 17 (46%) | 13 (34%) | 30 (41%) |
| No | 20 (54%) | 25 (66%) | 44 (59%) |
| NAe | 23 | 24 | 47 |
| MRI responsef | |||
| Favorable | 50 (83%) | 52 (87%) | 102 (84%) |
| Non-favorable | 10 (17%) | 8 (13%) | 18 (15%) |
| NA | 0 | 2 | 2 |
| Breast conserving surgery | 28 (47%) | 36 (58%) | 64 (52%) |
| Radiotherapy | 44 (73%) | 52 (84%) | 96 (79%) |
aAs assessed by the treating physician, LH, FSH and 17-beta-estradiol were tested in case of doubt.
bPatients with a sporadic profile or for whom no copy number profile could be obtained have been included in the HRD population of this trial based on a BRCA1 or BRCA2 germline mutation or BRCA1 promotor methylation.
cDuring the conduct of this trial, germline genetics testing typically only included BRCA1 and BRCA2.
dLocal guidelines recommended referral for germline genetics testing for women diagnosed with triple-negative breast cancer before the age of 50. Germline mutation status was updated during follow-up if new information became available.
eBRCA1 promoter hypermethylation testing was only mandatory if results for the BRCA1-like test could not be obtained and if the patient did not have a BRCA1 or BRCA2 germline mutation. In other cases, BRCA1 promoter hypermethylation testing depended on the amount of remaining tissue from the biopsy.
fAfter the first 3 cycles of neoadjuvant ddAC.