Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
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To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT) [ Time Frame: after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen ]
Secondary Outcome Measures
To assess the ability to deliver the trastuzumab and vinorelbine therapy [ Time Frame: After LPLV ]
To assess everolimus, trastuzumab and vinorelbine blood levels in this combination [ Time Frame: After LPLV ]
To evaluate the overall tumor response [ Time Frame: every 9 weeks/minus 1 week ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female or male patients ≥18 years with WHO performance status ≤ 1
HER-2 overexpressing metastatic breast cancer cells confirmed by histology
Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy
Patients neurologically stable with adequate bone marrow, liver and renal function
Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
Patients who have previously received vinorelbine or mTOR inhibitors
Other protocol-defined inclusion/exclusion criteria may apply