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Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients

NCT02642458 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-02-05

No results posted yet for this study

Summary

Despite the clear benefit of a combination therapy of pertuzumab plus trastuzumab plus docetaxel when compared with a combination therapy of trastuzumab and docetaxel the study populations of the CLEOPATRA trial might be slightly different from a patient population, in which pertuzumab, plus trastuzumab plus chemotherapy or trastuzumab plus chemotherapy are applied in routine clinical practice.

This non-interventional approach aims to confirm the clinically relevant outcomes shown in the phase III CLEOPATRA study in patients with advanced HER2-positive breast cancer in routine practice. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.

Data on efficacy, safety, tolerability and quality of life will be documented for this purpose. Following the recommendations as laid down in guidelines for treatment of breast cancer, the quality of life of patients will be assessed on a regular basis.

Conditions

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Diethelm Wallwiener, Prof. Dr. · Universitätsfrauenklinik Tübingen

  • Peter Fasching, Prof. Dr. · Frauenklinik des Universitätsklinikums Erlangen

  • Sara Brucker, Prof. Dr. · Universitätsklinikum Tübingen Universitäts-Frauenklinik

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-03-31
Completion
2020-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642458 on ClinicalTrials.gov