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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; HER-2 Gene Amplification

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.

• Study Type: Observational
• Enrollment (Anticipated): 63

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Hélène SIMON; Email: helene.simon@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic breast cancer HER2 positive who received pertuzumab in combination with trastuzumab and taxane chemotherapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Anticipated): July 22, 2019
• Study Completion (Anticipated): July 22, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Trastuzumab; Pertuzumab; Real life; Multicenter Study; Antibodies, Monoclonal, Humanized; Breast Neoplasms/pathology; Receptor, ErbB-2/antagonists & inhibitors*; Breast Neoplasms/drug therapy*; Taxoids
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: EPTTCSM (239BRC18.0129)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No