Estrogen receptor positive locally advanced or metastatic breast cancer in postmenopausal women MedDRA version: 14.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, whose disease recurred or progressed following a NSAI treatment. Letrozole or anastrozole do not have to be last treatment prior to study enrollment. 2. Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer and/or progesterone receptor-positive (PgR+) 3. Postmenopausal women. Postmenopausal status is defined either by: • Age = 55 years and one year or more of amenorrhea • Age =65 years) yes F.1.3.1 Number of subjects for this age range 1700
Exclusion criteria
Exclusion criteria: 1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive). 2. Pre-menopausal, pregnant, lactating women 3. Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or to their excipients. 4. Known hypersensitivity to exemestane, to the active substance or to any of the excipients. 5. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption. 6. Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment. 7. Currently receiving hormone replacement therapy, unless discontinued prior to enrollment. 8. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below: Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intraarticular) should not be given. However, during the study: • short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic) ; • low doses of corticosteroids for brain metastasis treatment is allowed 9. Patients with symptomatic visceral disease in need of urgent disease control 10. Symptomatic brain or other CNS metastases. Previously treated symptomatic brain metastases are allowed provided the patient is free of symptoms, prior radiotherapy for brain metastasis was more than four weeks before enrollment and the dose of corticosteroids is low and stable for at least two weeks prior to enrollment Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Adverse events: continuously, up to 28 days after last treatment Laboratory values: continuously or as frequently as clinically indicated;Main Objective: to evaluate safety of everolimus (RAD001) in postmenopausal women with hormone receptor positive locally advanced or metastatic breast cancer after recurrence or progression following NSAIs treatment;Secondary Objective: - to evaluate adverse events grade 3 and 4 in the routine practice - to explore the tolerability of the concomitant treatment of zoledronic acid RTU (Ready To Use) formulation in patients who will receive this treatment according to the clinical practice;Primary end point(s): frequency of adverse events and number of laboratory values that are new or worsening | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - frequency of adverse events that is recorded as Grade 3 or 4 or as Serious Adverse Event - frequency of adverse events of any grade in the group of patients who have received concomitant treatment with zoledronic acid RTU formulation, administered according to clinical practice ;Timepoint(s) of evaluation of this end point: Continuously, up to 28 days after the last treatment | — |
Countries
Austria, Belgium, Bulgaria, Denmark, Finland, Hungary, Ireland, Italy, Netherlands, Norway, Slovakia, Spain, Sweden
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed