Clinical trial NCT03979911: Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
Official title: Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
HER-2 Gene Amplification
Keywords: Pertuzumab
Breast Neoplasms/pathology
Real life
Trastuzumab
Receptor, ErbB-2/antagonists & inhibitors*
Breast Neoplasms/drug therapy*
Multicenter Study
Taxoids
Antibodies, Monoclonal, Humanized
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer HER2 positive who received pertuzumab in combination with trastuzumab and taxane chemotherapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion, an average of 1 year
measure: overall survival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: comparison of the age of our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort
timeFrame: at the inclusion
measure: safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: