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

• Status: Completed
• Trial end date: 2014-12-04
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Anastrozole; Estrogens; Everolimus; Exemestane; Letrozole; Sirolimus

Criteria

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