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Table 1 Demographic and baseline clinical characteristics

From: Nintedanib plus letrozole in early breast cancer: a phase 0/I pharmacodynamic, pharmacokinetic, and safety clinical trial of combined FGFR1 and aromatase inhibition

Characteristic Level N (%)
Age (years; median, range) Level 1 50.6 (50.1–51.5)
Level 2 59.5 (53.4–69.2)
Total 57.5 (50.1–69.2)
ECOG Level 1 0: 3/3 (100%)
Level 2 0: 16/16 (100%)
Total 0: 19/19 (100%)
Tumor size Level 1 T1: 3/3 (100%)
Level 2 T1: 8/16 (50%); T2: 8/16 (50%)
Total T1: 11/19 (58%); T2: 8/19 (42%)
Nodal status Level 1 N0: 2/3 (66.6%); N1: 1/3 (33.3%)
Level 2 N0: 9/16 (56.2%); N1: 6/16 (37.5%); N2: 1/16 (6.2%)
Total N0: 11/19 (57.9%), N1: 7/19 (36.8%); N2: 1/19 (5.3%)
ER and/or PR > 5% Level 1 3/3 (100%)
Level 2 16/16 (100%)
Total 19/19 (100%)
HER2 Level 1 0/3 (0%)
Level 2 0/16 (0%)
Total 0/19 (0%)
Grade Level 1 G1: 3/3 (100%)
Level 2 G1: 9/16 (56%); G2: 6/16 (38%); G3: 1/16 (6%)
Total G1: 12/19 (64%); G2: 6/19 (31%); G3: 1/19 (5%)
Ki67 (average, range) Level 1 9% (3–15%)
Level 2 11.5% (2–43%)
Total 11.1% (2–43%)
Adjuvant/neoadjuvant chemotherapy prior to study registration Level 1 0/3 (0%)
Level 2 Anthracyclines plus taxanes: 5/16 (31.3%); taxanes only: 1/16 (6.2%); none: 10/16 (62.5%)
Total Anthracyclines plus taxanes: 5/19 (26.4%); taxanes only: 1/19 (5.3%); none: 13/19 (68.3%)
Letrozole time (days) at study registration (average, range)* Level 1 134 (131–140)
Level 2 117 (29–220)*
Total 119 (29–220)*
  1. *The trial allowed patients that had completed their adjuvant treatment and had already started letrozole for a minimum of 4 weeks. Two patients started letrozole before scheduled adjuvant radiation therapy, and because of this reason, they had been receiving letrozole for 209 and 220 days. However, since they did not receive other modality of non-standard adjuvant treatment in between, they were allowed to enter the trial despite a maximum pre-established boundary of 180 days in letrozole prior to study registration