Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

Inclusion Criteria:

* Postmenopausal women as defined in the protocol page 9;
* Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
* Confirmed ER/PR-positive, and HER-2 negative tumor;
* Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
* Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
* ECOG performance status ≤ 2 or Karnofsky performance status ≥ 50% prior to the start of study treatment;
* Adequate organ function prior to the start of study treatment as defined in the protocol;
* Able to swallow and retain oral medication;
* Able to give written informed consent;

Exclusion Criteria:

* Male patient;
* Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
* History of brain or other CNS metastases;
* Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped \>1 year before metastatic relapse;
* Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
* History of neurological or psychiatric disorders;
* Any serious cardiovascular diseases in the previous 6 months;
* Impairment of gastrointestinal function or gastrointestinal disease;
* Patients with uncontrolled infection;
* Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day);
* Chronic treatment with systemic steroids or another immunosuppressive agent;
* Patients with a pre-existing peripheral neuropathy \> grade 1;
* Patients who are hepatitis B and/or hepatitis C carriers;
* Known human immunodeficiency virus infection;
* Prior exposure to mTOR inhibitors;
* Hypersensitivity to rapamycin or other similar compounds;
* Patients taking medications known to be inhibitors or inducers of CYP3A4 and/or PgP will not be included in this study;
* Prior treatment with any investigational agent within the preceding 4 weeks;
* Other conditions in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Other protocol-defined inclusion/exclusion criteria may apply.