TABLE 1

Patient Demographics

DemographicVariableAll registered patientsPrimary aim analysis (n = 51)Ki-67 analysis (n = 73)
Mean age ± SD (y)51.3 ± 10.952.5 ± 10.651.5 ± 10.2
Ethnicity Hispanic or Latino9 (10%)3 (5.9%)6 (8.2%)
 Not Hispanic or Latino75 (83.3%)43 (84.3%)62 (84.9%)
 American Indian, Alaska Native, Asian3 (3.3%)2 (4%)3 (4.1%)
 Black or African American25 (27.8%)12 (23.5%)19 (26%)
 White51 (56.7%)32 (62.7%)43 (58.9%)
Mean tumor size ± SD (cm)4.4 ± 2.54.6 ± 2.54.4 ± 2.4
Menopausal status Premenopausal42 (46.7%)22 (43.1%)33 (45.2%)
 Postmenopausal47 (52.2%)29 (56.9%)39 (53.4%)
Initial diagnosis Invasive breast cancer NOS2 (2.2%)2 (3.9%)2 (2.7%)
 Invasive ductal77 (85.5%)43 (84.4%)63 (86.3%)
 Invasive lobular + mixed invasive & lobular10 (11.1%)6 (11.8%)8 (11%)
Estrogen receptor status Positive49 (54.4%)29 (56.9%)43 (58.9%)
 Negative40 (44.4%)22 (43.1%)30 (41.1%)
Progesterone receptor status Positive38 (42.2%)20 (39.2%)35 (47.9%)
 Negative51 (56.7%)31 (60.8%)38 (52.1%)
HER2 status Positive32 (35.6%)15 (29.4%)22 (30.1%)
 Negative54 (60%)34 (66.7%)48 (65.8%)
Receptor status Triple negative22 (24.4%)13 (25.5%)19 (26%)
 Other64 (71.1%)36 (70.6%)51 (69.9%)
T stage TX3 (3.3%)3 (5.9%)3 (4.1%)
 T11 (1.1%)NANA
 T242 (46.7%)23 (45.1%)35 (47.9%)
 T331 (34.4%)19 (37.3%)25 (34.2%)
 T412 (13.3%)6 (11.7%)10 (13.7%)
Pathologic N stage pNX3 (3.3%)3 (5.9%)3 (4.1%)
 pN026 (28.9%)13 (25.5%)23 (31.5%)
 pN145 (50.0%)27 (53%)35 (48.0%)
 pN210 (11.1%)5 (9.8%)8 (11%)
 pN35 (4.4%)3 (5.9%)4 (5.5%)
Stage IIA19 (21.1%)10 (19.6%)16 (21.9%)
 IIB32 (35.6%)18 (35.3%)26 (35.6%)
 IIIA22 (24.4%)14 (27.5%)18 (24.7%)
 IIIB9 (10%)5 (9.8%)8 (11%)
 IIIC4 (4.4%)3 (5.9%)4 (5.5%)
 IV2 (2.2%)NANA
Grade at diagnosis 12 (2.2%)1 (2%)2 (2.7%)
 219 (21.1%)12 (23.5%)17 (23.3%)
 344 (48.9%)27 (52.9%)33 (45.2%)
  • Percentages not adding up to 100% are due to missing data; tumor size was determined using baseline imaging.

  • NOS = not otherwise specified; HER2 = human epidermal growth factor receptor type 2; NA = not applicable.