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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive) Older than 18 years Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes Having the patient's complete medical history that contains all lines antiHER2 therapy treatment Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011 Inform the patient and get the signature of the informed consent Exclusion Criteria: Not having phenotypic classification of the tumor by IHC or FISH test for HER2 Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH) Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy Being a patient who, since January 2012, began TL therapy for metastatic disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate assessed by RECIST criteria | 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 | Up to 24 weeks from the first clinical response rate assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib | The progression will be evaluated by RECIST v 1.1. | Up to one year from the last dose of TL | 
| To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines. | clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks | Up to 24 weeks from the last dose of TL | 
| To compare the time to progression of different subpopulations according to the biological characteristics of the tumor. | The progression will be evaluated by RECIST v 1.1. | Up to one year from the last dose of TL | 
| To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit | Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4 | Up to one year from the last dose of TL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasm, quinazolines, Receptor,HER2, Antineoplastic agent, Antibodies, monoclonal, Trastuzumab, Lapatinib, Protein kinase inhibitors