A phase Ib study investigating the combination of RAD001 with trastuzumab and vinorelbine in patients with HER2- overexpressing metastatic breast cancer - ND

Conditions: HER2 overexpressing metastatic breast cancer
MedDRA version: 9.1Level: LLTClassification code 10021977Term: Inflammatory carcinoma of breast recurrent

Registration Number: EUCTR2006-001595-20-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Female or male patients 8805;18 years WHO performance status 8804;1 Histologically confirmed diagnosis of metastatic breast cancer demonstrating HER2-overexpression IHC 3 or FISH positive Progressive disease on prior trastuzumab alone or in combination with other anticancer agents, or relapsed any time after completion of this therapy Patients may have received treatment with lapatinib or other HER2 targeted therapies after progression on trastuzumab Patients may have received adjuvant chemotherapy and one or more prior chemotherapies for advanced disease Measurable or non-measurable disease according to RECIST Patients may have received treatment for brain metastases, but must be neurologically stable and off corticosteroids Baseline LVEF 50 MUGA or echo Adequate bone marrow function as shown by Absolute Neutrophil Count ANC 8805; 1.5 x 109/L Platelets 8805; 100 x 109/L Hemoglobin Hgb 8805; 9g/dL Adequate liver function as shown by Serum aspartate aminotransferase AST and alanine aminotransferase ALT 8804; 2.5 ULN or 8804; 5 if hepatic metastases are present Total bilirubin 8804; 1.5 x ULN INR 1.3 x ULN or 3 ULN on antigoagulants Adequate renal function as shown by Serum creatinine 8804; 1.5 x ULN Women using an acceptable form of contraception or women who meet the protocol definition of post-menopausal 12 months of natural spontaneous amenorrhea or 6 months of spontaneous or induced amenorrhea with serum FSH levels 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy Patients who give a written informed consent obtained according to local guidelines
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients receiving endocrine therapy for breast cancer endocrine therapy must have either failed in patients with hormone receptor positive disease or patients must be considered unsuitable for endocrine therapy Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have received these 8804;4 weeks prior to study treatment start Patients who have previously received vinorelbine Patients who have previously received mTOR inhibitors Patients with a known hypersensitivity to RAD001 everolimus or other rapamycins sirolimus, temsirolimus or to its excipients Patients receiving chronic treatment with steroids or another immunosuppressive agent Patients who are using other investigational agents or who had received investigational drugs 8804; 4 weeks prior to study treatment start Patients who have received radiotherapy 8804; 4 weeks prior to study treatment start or who have not recovered from such therapy Patients who have undergone major surgery 8804; 2 weeks prior to starting study treatment or who have not recovered from such therapy Patients with uncontrolled or symptomatic CNS disease Patients with a known history of HIV seropositivity HIV testing is not mandatory Patients with an active, bleeding diathesis or on oral anti-vitamin K medication except low dose coumadin Patients treated with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A Persistent 8805;Grade 2 neuropathy or history of grade 3/4 neuropathy of any etiology Patients who have any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 8804; 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia uncontrolled diabetes as defined by fasting serum glucose 1.5X ULN 8805; grade 3 hypercholesterolemia / hypertriglyceridemia or 8805; grade 2 hypercholesterolemia / hypertriglyceridemia with history of coronary artery disease despite lipid-lowering treatment if given 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 impairment of gastrointestinal function or who have gastrointestinal disease that may significantly alter the absorption of RAD001 e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome active skin, mucosa, ocular or GI disorders of grade 1 pulmonary insufficiency or diseases that lead to impairment of lung function Patients who have liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Unless demonstrated to be post-menopausal see inclusion criteria , pregnancy should be excluded by serum pregnancy test 8804; 48 hours prior to the administration of the first study treatment. History of noncompliance to medical regimens Patients unwilling to or unable to comply with the protocol