exemestane plus everolimus for hormone-receptor positive metastatic breast cancer

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Summary: the purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.

postmenopausal women with hr-positive, her2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.

Eligibility criteria:
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.