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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|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|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- 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
- To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib [ Time Frame: Up to one year from the last dose of TL ]The progression will be evaluated by RECIST v 1.1.
- To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines. [ Time Frame: Up to 24 weeks from the last dose of TL ]clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks
- To compare the time to progression of different subpopulations according to the biological characteristics of the tumor. [ Time Frame: Up to one year from the last dose of TL ]The progression will be evaluated by RECIST v 1.1.
- To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit [ Time Frame: Up to one year from the last dose of TL ]Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056080
|Santiago de Compostela, Spain|
|Principal Investigator:||Joaquin Gávila, MD||Valencia|