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

NCT ID: NCT03979911

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2019-07-22

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms HER-2 Gene Amplification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Helene SIMON

Role: CONTACT

02-98-22-34-51

Paul Bore

Role: CONTACT

Facility Contacts

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Hélène SIMON

Role: primary

Other Identifiers

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EPTTCSM (239BRC18.0129)

Identifier Type: -

Identifier Source: org_study_id

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