Breast Neoplasms, HER-2 Gene Amplification
Conditions
Keywords
Pertuzumab, Breast Neoplasms/pathology, Real life, Trastuzumab, Receptor, ErbB-2/antagonists & inhibitors*, Breast Neoplasms/drug therapy*, Multicenter Study, Taxoids, Antibodies, Monoclonal, Humanized
Brief summary
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
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.
Interventions
None listed
Sponsors
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | through study completion, an average of 1 year | time between inclusion and progression of the disease |
| overall survival | through study completion, an average of 1 year | time between inclusion and death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE | through study completion, an average of 1 year | % of patient with an adverse event under treatment with grade \>2 according to CTCAE |
| comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with visceral metastasis in our study are compared to those of Cleopatra cohort |
| comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with brain metastasis in our study are compared to those of Cleopatra cohort |
| comparison of the age of our population to those of the CLEOPATRA cohort | at the inclusion | % 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 |
| comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with an amplication of HER 2 detected in immunohistochemistry in our study are compared to those of Cleopatra cohort |
| comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with a performance status \>1 in our study are compared to those of Cleopatra cohort |
| comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with positive hormonal receptors in our study are compared to those of Cleopatra cohort |
| comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort | at the inclusion | % of patients with adjuvant or neo-adjuvant chemotherapy in our study are compared to those of Cleopatra cohort |
Countries
France
Contacts
Primary ContactHelene SIMON
Backup ContactPaul Bore
Outcome results
None listed