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: 14.1Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003065-17-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Study Completion: 2021-01-13
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 202

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 142
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

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