Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib (TRASTYVERE)
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ClinicalTrials.gov Identifier: NCT02056080 |
Recruitment Status :
Completed
First Posted : February 5, 2014
Last Update Posted : September 9, 2019
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Sponsor:
MedSIR
Information provided by (Responsible Party):
MedSIR
Tracking Information | ||||
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First Submitted Date | January 10, 2014 | |||
First Posted Date | February 5, 2014 | |||
Last Update Posted Date | September 9, 2019 | |||
Actual Study Start Date | January 2013 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Clinical response rate assessed by RECIST criteria [ Time Frame: Up to 24 weeks from the first clinical response rate assessment ] clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL.
This variable will be assessed by RECIST v 1.1
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib | |||
Official Title | Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib | |||
Brief Summary | A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011 | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL). | |||
Condition | Breast Neoplasm | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
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 | Completed | |||
Actual Enrollment |
111 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02056080 | |||
Other Study ID Numbers | MED-DBL-2012-01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | MedSIR | |||
Study Sponsor | MedSIR | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | MedSIR | |||
Verification Date | September 2019 |