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

Novartis

Status and phase

Completed

Phase 3

Conditions

Post Menopausal Breast Cancer

Treatments

Drug: exemestane

Drug: everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT03176238

CRAD001JIC06

Details and patient eligibility

About

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Enrollment

235 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.