A Randomized Double-Blind, Placebo-Controlled Study of 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. - CRAD001Y2301

• Conditions: Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer; MedDRA version: 17.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-008698-69-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-14
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 705

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 objective 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
•Adequate bone marrow and coagulation function
•Adequate liver and renal function
•ECOG Performance Status = 2 or less
Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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,
•Patients receiving immunosuppressive agents or chronic corticosteroids use
•Patients being treated with strong inhibitors or inducers of CYP3A within 5 days prior to randomization

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer refractory to NSAIs.;Secondary Objective: Key Secondary Objective<br>?To compare overall survival (OS) between the 2 treatment arms<br><br>Other Secondary Objectives<br>?To evaluate the two treatment arms with respect to <br> ?Overall response rate (ORR)<br> ?Time to deterioration of ECOG Performance Status <br> ?Safety <br> ?Change in QoL scores over time<br> ?Clinical benefit rate (CBR)<br>;Primary end point(s): progression-free survival (PFS), defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause.