Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole (BOLERO-2)

Novartis

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Everolimus Placebo; Drug: Exemestane; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863655

CRAD001Y2301

2008-008698-69 (EudraCT Number)

Details and patient eligibility

About

There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Enrollment: 724 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
• Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
• Postmenopausal women.
• Disease refractory to non steroidal aromatase inhibitors (NSAI),
• Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
• Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.

Exclusion criteria

• HER2-overexpressing patients
• Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
• Patients who received more than one chemotherapy line for Advanced Breast Cancer.
• Previous treatment with exemestane or mTOR inhibitors.
• Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
• Radiotherapy within four weeks prior to randomization
• Currently receiving hormone replacement therapy,

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

724 participants in 2 patient groups

Everolimus + Exemestane

Experimental group

Description:

Everolimus 10 mg daily in combination with exemestane 25 mg daily

Treatment:

Drug: Exemestane

Drug: Everolimus

Placebo + Exemestane

Active Comparator group

Description:

Placebo of everolimus in combination with exemestane 25 mg daily

Treatment:

Drug: Exemestane

Drug: Everolimus Placebo