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

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

HER-2 Gene Amplification
Breast Neoplasms

Study type

Observational

Funder types

Other

Identifiers

NCT03979911
EPTTCSM (239BRC18.0129)

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Helene SIMON; Paul Bore

Data sourced from clinicaltrials.gov

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