Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)

This is an interventional treatment trial for Post Menopausal Breast Cancer focused on measuring post menopausal, advanced breast cancer, metastatic breast cancer, everolimus, exemestane, mTor inhibitor, endocrine therapy, human epidermal growth factor, estrogen receptor positive, adult, CRAD001 Read More

Inclusion Criteria:

• Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
• Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
• Disease refractory to non-steroidal aromatase inhibitors, defined as:
• Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
• Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
• Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
• Patients must have had:

• At least one lesion that could have been accurately measured in at least one dimension

  • 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
• Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
• Adequate bone marrow, coagulation, liver and renal function.
• ECOG performance status ≤ 2.

Exclusion Criteria:

• Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
• Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
• Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
• Previous treatment with mTOR inhibitors.
• Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
• Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
• Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
• History of brain or other CNS metastases, including leptomeningeal metastasis.