Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer

Study Overview
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Brief Summary
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This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

Detailed Description
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In 2013 the European Medicines Agency authorized the use of a new antibody named Pertuzumab in combination with Trastuzumab in first-line setting for patients with HER2-positive metastatic breast cancer. The efficacy and the safety were demonstrated in the CLEOPATRA study. This study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. Few study tried to evaluate this treatment in real life settings but with discordant results. This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

Official Title
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Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer

Conditions
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Breast Neoplasms, HER-2 Gene Amplification

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: metastatic breast cancer HER2 positive Received pertuzumab in combination with trastuzumab and taxane chemotherapy Exclusion Criteria: no HER2-positive breast cancer no association with taxane chemotherapy no metastatic breast cancer refusal to consent
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 |
| --- | --- | --- |
| Progression-free survival | time between inclusion and progression of the disease | through study completion, an average of 1 year | 
| overall survival | time between inclusion and death | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of the age of our population to those of the CLEOPATRA cohort | % of patients with an age <65 years and > 65 years and <75 years and > 75 years in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort | % of patients with adjuvant or neo-adjuvant chemotherapy in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort | % of patients with visceral metastasis in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort | % of patients with brain metastasis in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort | % of patients with positive hormonal receptors in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort | % of patients with an amplication of HER 2 detected in immunohistochemistry in our study are compared to those of Cleopatra cohort | at the inclusion | 
| comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort | % of patients with a performance status >1 in our study are compared to those of Cleopatra cohort | at the inclusion | 
| safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE | % of patient with an adverse event under treatment with grade >2 according to CTCAE | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertuzumab, Breast Neoplasms/pathology, Real life, Trastuzumab, Receptor, ErbB-2/antagonists & inhibitors*, Breast Neoplasms/drug therapy*, Multicenter Study, Taxoids, Antibodies, Monoclonal, Humanized