Status:
COMPLETED
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II...
Eligibility Criteria
Inclusion
- Female or male patients ≥ 18 years old with WHO performance status ≤ 1
- HER-2 over-expressing 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 (phase l)
- Patient resistance to trastuzumab and taxanes (Phase ll)
- Measurable disease according to RECIST (Phase ll)
- Patients neurologically stable with adequate bone marrow, liver and renal function
Exclusion
- 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 mTOR inhibitors
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00426556
Start Date
July 1 2007
End Date
March 1 2014
Last Update
December 28 2015
Active Locations (20)
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1
Wilshire Oncology Medical Group La Verne
*see Various Departments*, California, United States
2
Compassionate Cancer Care Medical Group Dept.ofCCCMG
Fountain Valley, California, United States, 92708
3
Loma Linda University Dept.ofLomaLindaCancerCent(3)
Loma Linda, California, United States, 92354
4
University of California at Los Angeles Dept.of UCLA Dept.ofMed.
Los Angeles, California, United States, 90095