Table 1.

Patient demographics and baseline characteristics and disease characteristics.

Alpelisib + tamoxifen + goserelin (n = 16)Buparlisib + tamoxifen + goserelin (n = 13)
Age, yearsMedian (range)45.5 (28–54)46.0 (36–54)
Age group, n (%)18–35 years1 (6.3)0
36–45 years7 (43.8)5 (38.5)
46–55 years8 (50.0)8 (61.5)
ECOG performance status, n (%)015 (93.8)9 (69.2)
11 (6.3)4 (30.8)
Disease status, n (%)Metastatic15 (93.8)13 (100)
 De novo7 (43.8)6 (46.2)
 Recurrent8 (50.0)7 (53.8)
Locally advanced1 (6.3)0
Liver and/or lung disease, n (%)Present9 (56.3)7 (53.8)
Absent7 (43.8)6 (46.2)
Measurable disease per RECIST version 1.1, n (%)Yes16 (100)11 (84.6)
No02 (15.4)
Bone-only metastases, n (%)Yes5 (33.3)1 (7.7)
No10 (66.7)12 (92.3)
Previous chemotherapy, n (%)Metastatic setting1 (6.3)0
Adjuvant/neoadjuvant only6 (37.5)7 (53.8)
None9 (56.3)6 (46.2)
Previous endocrine therapy in adjuvant setting, n (%)Yes5 (31.3)3 (23.1)
No11 (68.8)10 (76.9)
Previous treatment with tamoxifen in adjuvant setting, n (%)Yes5 (31.3)3 (23.1)
No11 (68.8)10 (76.9)
Tamoxifen-resistant disease, n (%)aYes4 (25.0)2 (15.4)
Underwent primary surgery for breast cancer, n (%)Lumpectomy2 (12.5)2 (15.4)
Mastectomy6 (37.5)6 (46.2)
Axillary LN dissection03 (23.1)
None8 (50.0)2 (15.4)
Previous radiotherapy, n (%)Adjuvant3 (18.8)3 (23.1)
Metastatic01 (7.7)
No13 (81.3)9 (69.2)
Histology/cytology, n (%)Invasive ductal carcinoma13 (81.3)10 (76.9)
Invasive lobular carcinoma3 (18.8)2 (15.4)
Other01 (7.7)
  • Note: Percentages were calculated using the FAS as the denominator, except for sites of metastatic disease. Percentages of patients with a recorded site of metastatic disease were calculated using the number of patients with any metastatic disease as the denominator.

  • Abbreviations: ECOG, Eastern Cooperative Oncology Group; LN, lymph node; RECIST, Response Evaluation Criteria in Solid Tumors.

  • aTamoxifen-resistant disease is defined as disease recurrence during treatment with tamoxifen in the adjuvant setting.