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: 16.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Afinitor
Product Code: RAD001
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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: o At least one lesion that can be accurately measured or o Bone 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Overall Response Rate (ORR) in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with NSAIs treated with the combination of Everolimus and Exemestane.;Secondary Objective: To evaluate the following objectives: • Progression free survival (PFS) • Overall survival (OS) • Safety • Change in QoL scores over time • Health resource utilization ;Primary end point(s): Overall response rate (ORR) ;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment • ORR after 48 weeks of treatment • Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. • Safety will be assessed with the Common Terminology Criteria (CTCAE), version 4.03. Incidence of adverse events, serious adverse events, changes from baseline in vital signs, ECOG performance status and laboratory results (hematology, blood chemistry) will be reported. • The following questionnaires will be used to collect QoL data: EORTC QLQ-C30 & BR23, HADS D, EQ-5D. Scoring and statistical analysis will follow the respective manuals. • Overall treatment cost, cost effectiveness ranges as well as the quality adjusted life years (QALY) and incremental cost effectiveness ratios (ICER) compared to usual therapies in this setting (endocrine therapy alone, e.g. Fulvestrant, Exemestane mono or chemotherapy). ;Timepoint(s) of evaluation of this end point: after 24 and 48 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed