Table 1.

Characteristics of patients with AR(+) tumors

Eligible patients treated with bicalutamide (N = 26)Patients not treated with bicalutamide/ineligible (N = 25)
CharacteristicsNo. of pts (n)No. of pts (n)
ER/PgR
 0%2216
 1%–10%45
 >10%NA4
HER2-positive16
Site of AR testing
 Primary1714
 Metastatic911
Median age (range), y66 (41–83)58 (30–76)
Median ECOG PS (range)0 (0–1)NAa
Sites of metastases
 Visceral metastases15NAa
 Thoracic/pleural (9), hepatic (8), gastric (1), adrenal (2)
 Bone/soft tissue/lymph node metastases21NAa
Measurable22NAa
Nonmeasurable4NAa
Prior chemotherapy for early-stage breast cancer
 Adjuvant13NAa
 Neoadjuvant7NAa
Number of patients with de novo MBC2NAa
Prior chemotherapy for MBC
 Median number of regimens (range)1 (0–8)NAa

NOTE: HER2-positive defined as IHC 3+ or FISH > 2.

  • aTBCRC011 involved a 2-step enrollment process that allowed patients with ER/PgR(−) breast cancer that was metastatic to be tested for AR without enrolling in the therapeutic portion of the trial. Therefore, the patients who tested AR-positive but did not consent to therapy did not have clinical data collected aside from ER, PR, HER2, age, and site of disease tested for AR.