HR+ / HER2 negative metastatic breast cancer MedDRA version: 16.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Afinitor
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they met all the following criteria 1. >18 years old women with metastatic breast cancer 2. Histological confirmation of hormone-receptor positive (defined as at least 10% of ER and/or PgR positivity) and HER2 negative (score 0-1+ in immunohistochemistry or FISH negativity) breast cancer 3. Postmenopausal status, defined by at least one of the following: -60 years of age; - /=12 months prior to day 1 - =65 years) yes F.1.3.1 Number of subjects for this age range 169
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons: 1..HER2-overexpressing patients by local laboratory testing (immunohistochemistry 3+ staining or in situ hybridization positive) 2..Previous treatment with mTOR inhibitors 3..Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) 4..More than one chemotherapy line for metastatic disease 5..Treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab) 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..Symptomatic central nervous system metastases 8..Patients with a known history of HIV positivity 9..Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the INR is = 2.0) 10..Any severe and / or uncontrolled medical conditions such as: a...Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =6 months prior to enrollment, serious uncontrolled cardiac arrhythmia b...Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN c...Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy d...Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) e...Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco and O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates. 11..Patients who test positive for hepatitis B or C (patients who test negative for HBV-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible) 12..Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritinavir, Telithromycin) within the last 5 days prior to enrollment 13..History of non-compliance to medical regimens 14..Patients unwilling to or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression free survival (PFS) of AIs/everolimus to AIs administered as maintenance therapy in HR+ advanced breast cancer patients with disease control (CR+PR+SD) after at least 6 courses of first line chemotherapy. ;Secondary Objective: - To evaluate the overall survival - To assess the safety profile - To evaluate the response rate ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Time from randomization to the first documentation of objective disease progression or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: The interval between the date of randomization and the date of patient death due to any cause, or the last date the patient was known to be alive. | — |
Countries
Italy
Contacts
Public ContactClin Trials and Biostatistics Servi
Istituto Oncologico Veneto
Outcome results
None listed