Table 1 Characteristics of patients and tumors at baseline (n = 99)

From: Patritumab deruxtecan in HR+HER2 advanced breast cancer: a phase 2 trial

Age

 Median (range), years

57.0 (48.0–66.0)

Sex, n (%)

 Female

99 (100.0)

ECOG PS, n (%)

 0

56 (56.6)

 1

40 (40.4)

 N/A

3 (3.0)

Menopausal status, n (%)

 Premenopausal

23 (23.2)

 Postmenopausal

75 (75.8)

 N/A

1 (1.0)

Stage at initial tumor diagnosis, n (%)

 I

13 (13.1)

 II

19 (19.2)

 III

11 (11.1)

 IV

30 (30.3)

N/A

26 (26.3)

HR status at initial tumor diagnosis, n (%)

 ER+PR+

76 (76.8)

 ER+PR

18 (18.2)

 ERPR

1 (1.0)

 N/A

3 (3.0)

HER2 expression at initial tumor diagnosis, n (%)

 IHC 0

56 (56.6)

 IHC 1+

22 (22.2)

 IHC 2+, ISH nonamplified

11 (11.1)

 IHC 2+, ISH amplified

1 (1.0)

 Unknown

9 (9.1)

HER2 expression on tumor biopsy at baseline, n (%)

 IHC 0a

39 (39.4)

 IHC 1+

22 (22.2)

 IHC 2+, ISH

7 (7.1)

 IHC 3+

1 (1.0)

 Unknown

30 (30.3)b

HER3 expression

Membrane H-score, median (range)

180 (0–290)

Overall membrane positivity at 10×, n (%)

 <25%

16 (16.2)

 25–74%

7 (7.1)

 ≥75%

49 (49.4)

 Unknown

27 (27.3)

Metastatic sites at study entry, n (%)

 Liver

60 (60.6)

 Lung

8 (8.1)

 Nodes

9 (9.1)

 Brain

0 (0)

Median number of systemic therapies for ABC, n (range)

2 (1–4)

Previous treatment with CDK4/ 6inh, n (%)

98 (99.0)c

Median duration of CDK4/6inh, months (range)

13.7 (2.9–42.0)d

Previous PI3K–AKT–mTOR inh for ABC, n (%)

35 (35.4)

Previous chemotherapy for ABC, n (%)

99 (100.0)

Type of chemotherapy for ABC, n (%)

 Capecitabine

53 (53.6)

 Taxanes

23 (23.2)

 Others

23 (23.2)

  1. a20 with HER2 membrane staining 1–10%.
  2. bInsufficient tumor tissue available.
  3. c96 patients had CDK4/6inh for ABC, 2 patients for early breast cancer; 1 patient was enrolled by mistake because did not receive any previous treatment with CDK4/6inh.
  4. dEvaluated on 73 patients.
  5. ECOG, Eastern Cooperative Oncology Group.