A clinical study to evaluate the safety and benefit from using Everolimus and Exemestane in combination in postmenopausal women with estrogen receptor positive breast cancer
- Conditions
- The trial aims to evaluate the efficacy, safety, quality of life and health resources in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with NSAIs treated with the combination of Everolimus and Exemestane.MedDRA version: 16.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006111-62-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
•Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy or any other non-systemic treatment.
•Histological or cytological confirmation of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) - negative breast cancer
•Postmenopausal women
•Progressing following prior therapy with non steroidal aromatase inhibitors (NSAI) with or without direct switching to steroidal AI treatment with Exemestane
•Patients must have:
oAt least one lesion that can be accurately measured or
oBone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
•HER2-overexpressing patients by local laboratory testing
•Non stable or non pre-treated brain metastases
•Patients with only non-measurable lesions other than bone metastasis
•Previous treatment with mTOR inhibitors
•Known hypersensitivity to mTOR inhibitors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method