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

Breast Neoplasms Clinical Trial

— EPTTCSM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979911
• Other study ID #: EPTTCSM (239BRC18.0129)
• Status: Recruiting
• Start date: January 22, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: November 2018
• Source: University Hospital, Brest
• Contact: Helene SIMON
• Phone: 02-98-22-34-51
• Email: helene.simon[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER-2 Gene Amplification
• Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	time between inclusion and progression of the disease	through study completion, an average of 1 year
Primary	overall survival	time between inclusion and death	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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