Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00426556 |
Recruitment Status
:
Completed
First Posted
: January 24, 2007
Results First Posted
: March 31, 2015
Last Update Posted
: December 28, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Tracking Information | ||||
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First Submitted Date ICMJE | January 23, 2007 | |||
First Posted Date ICMJE | January 24, 2007 | |||
Results First Submitted Date | March 20, 2015 | |||
Results First Posted Date | March 31, 2015 | |||
Last Update Posted Date | December 28, 2015 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Phase II: Overall Response Rate [ Time Frame: every 8 - 9 weeks until disease progression or a new lesion is identified ] The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
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Original Primary Outcome Measures ICMJE |
To establish the feasible dose levels/regimens based on end-of-cycle-1 dose limiting toxicity | |||
Change History | Complete list of historical versions of study NCT00426556 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer | |||
Official Title ICMJE | A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer | |||
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: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Breast Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
88 | |||
Original Enrollment ICMJE |
60 | |||
Actual Study Completion Date | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, France, Netherlands, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00426556 | |||
Other Study ID Numbers ICMJE | CRAD001J2101 2006-001596-37 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | November 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |