A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

Key Inclusion Criteria:

* Chinese Postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women. Postmenopausal status was defined either by:

  * Prior bilateral oophorectomy
  * Or age ≥60
  * Or age \< 60 and amenorrhea for 12 or more months
* Recurrence or progression on prior NSAI was defined as:

  * Recurrence while on, or within one year (12 months) of end of adjuvant treatment with letrozole or anastrozole
  * Or Progression while on or within one month (30 days) of the end of prior treatment with letrozole or anastrozole
* Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment
* Patient had as per RECIST 1.1

  * measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
  * non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
* Patient was able to swallow and retain oral medication
* Patient met the hematologic and biochemistery laboratory values at the screening visit
* Patient had a WHO performance status ≤2
* Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

* HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test.
* Patients who had received more than one chemotherapy line for ABC
* Patients with symptomatic visceral disease and candidates to chemotherapy
* Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis (e.g. pleural effusion, ascites etc.)
* Patients receiving concomitant immunosuppressive agents or chronic corticosteroids used at the time of study entry except topical applications, inhaled sprays, eye drops or local injections.
* Uncontrolled diabetes mellitus as defined by HbA1c \>7% despite adequate therapy.