Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

This is an interventional treatment trial for Hormone Receptor Positive Malignant Neoplasm of Breast Read More

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.