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

• Register: EUCTR
• Last refreshed on: 14 April 2014
• Main ID: EUCTR2011-006111-62-DE
• Date of registration: 29/03/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: 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
• Scientific title: A Phase IIIB, Multi-Center, Open Label Study For Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) in Combination With Exemestane - 4EVER
• Date of first enrolment: 11/07/2012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006111-62
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Germany

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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)

Intervention(s)

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
Concentration number: 5-

Trade Name: Exemestan cell pharm
Product Name: Exemestan
Pharmaceutical Form: Film-coated tablet
CAS Number: 107868-30-4
Other descriptive name: EXEMESTANE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

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
Concentration number: 10-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

Primary end point(s): Overall response rate (ORR)

Secondary Outcome(s)

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

Secondary ID(s)

CRAD001JDE49

Source(s) of Monetary Support

Novartis Pharma GmbH