- ER(+), HER2(-), postmenopausal adult (ages 18-65 years, inclusive) Chinese women with
proven diagnosis of adenocarcinoma of the breast with evidence locoregionally
recurrent or metastatic disease not amenable to resection or radiation therapy with
curative intent and for whom chemotherapy is not clinically indicated.
a. Postmenopausal women: i. Prior bilateral surgical oophorectomy; or ii. Medically
confirmed post-menopausal status defined as spontaneous cessation of regular menses
for at least 12 consecutive months with no alternative pathological or physiological
cause b. Documentation of histologically or cytologically confirmed diagnosis of: i.
ER(+) breast cancer. c. Documentation of HER2(-) breast cancer. d. Previously
untreated with any systemic anti cancer therapy for their locoregionally recurrent or
metastatic ER+ disease.
- Measurable disease as defined per RECIST v.1.1 or bone-only disease. - Tumor lesions
previously irradiated or subjected to other locoregional therapy will only be deemed
measurable if disease progression at the treated site after completion of therapy is
clearly documented.
- HER2-positive tumor as defined by documentation of erbB-2 gene amplification by FISH
(as defined by a HER2/CEP17 ratio ?2) or chromogenic in situ hybridization (CISH, as
defined by the manufacturer's kit instruction) or documentation of HER2 overexpression
by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local
laboratory results
- Patients with advanced, symptomatic, visceral spread, that are at risk of
life-threatening complications in the short term (including patients with massive
uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and
over 50% liver involvement).