Study of efficacy and safety of everolimus and letrozole in estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer patients

Phase 1

• Conditions: Estrogen receptor positive metastatic breast cancer; MedDRA version: 20.0 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

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