A clinical study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer

Phase 1

• Conditions: Estrogen receptor positive metastatic breast cancer; MedDRA version: 19.0Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003065-17-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-17
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

•Patients 18 years old or greater
•Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
•Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
•Postmenopausal women
•No prior treatment for metastatic breast cancer

Other protocol based 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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

•Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
•Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
•Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
•Previous treatment with mTOR inhibitors.
•Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
•Other protocol-defined inclusion/exclusion criteria may apply

Other protocol based 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: The primary objective is to estimate progression-free survival in patients treated with everolimus + letrozole in the first line metastatic setting.;Secondary Objective: - Determine the overall response rate and clinical benefit rate of everolimus + letrozole in the first line metastatic setting<br>- Determine the progression free survival and clinical benefit rate of everolimus + exemestane in second line population<br>- Estimate the overall survival of patients treated with everolimus + letrozole in the first line setting<br>- Evaluate a therapeutic intervention to reduce the severity and duration of stomatitis<br>- Evaluate the safety of everolimus + letrozole in the first line setting<br>- Evaluate the safety of everolimus + exemestane in the second line setting;Primary end point(s): Percentage of patients progression-free after completion of 1st line treatment (everolimus + letrozole);Timepoint(s) of evaluation of this end point: 12 months after last patient recruited