Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
- Conditions
- HER-2 Gene AmplificationBreast Neoplasms
- Registration Number
- NCT03979911
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 63
- metastatic breast cancer
- HER2 positive
- Received pertuzumab in combination with trastuzumab and taxane chemotherapy
- no HER2-positive breast cancer
- no association with taxane chemotherapy
- no metastatic breast cancer
- refusal to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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 % 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 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
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
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, France