Status:
COMPLETED
Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Neoplasms
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00426530
Start Date
February 1 2007
End Date
June 1 2010
Last Update
December 21 2020
Active Locations (6)
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1
Novartis Investigative Site
Brussels, Belgium, 1000
2
Novartis Investigative Site
Liège, Belgium, 4000
3
Novartis Investigative Site
Paris, France, 75231
4
Novartis Investigative Site
Milan, MI, Italy, 20133