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

NCT02642458 | Unknown DMC

• 1 other identifier: SEN2015-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 37

Brief 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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival rate

  The primary objective of this study is to assess the progression free survival rate at month 12 for both treatment cohorts in routine clinical practice treated with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel.

  At 12 months or month 36

Secondary Outcomes (5)

• Progression free survival

  Timepoint of progression or month 36

• Overall response rate

  Timepoint of progression or month 36

• Quality of life (EORTC QLQ-C30)

  At 12 months

• Incidence of adverse events and serious adverse events will be documented

  up 36 month

• Quality of life (EORTC QLQ-BR23)

  At 12 months

Study Arms (2)

trastuzumab plus chemotherapy

Treatment with trastuzumab plus chemotherapie as first line therapy, administered intravenously/subcutaneously in a three weekly frequency. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.

pertuzumab plus trastuzumab plus chemotherapy

Treatment with with pertuzumab plus trastuzumab plus chemotherapy as first line therapy, administered intravenously/subcutaneously in a three weekly frequency. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted as an open registry, therefore there will be no restriction in the number of patients to be included. The assignment of the patient to a particular treatment falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the non-interventional study.

You may qualify if:

• Adult breast cancer patients (age ≥18 years)
• Patients with metastatic or locally advanced, unresectable HER2-positive breast cancer proven by clinical measures (i.e. standard imaging) in first line treatment (Locally recurrent disease must not be amenable to resection with curative intent)
• Patients who are eligible for treatment with trastuzumab plus chemotherapy or pertuzumab plus trastuzumab plus chemotherapy as first line therapy, administered intravenously in a three weekly frequency, according to each center's medical practice. The first line anti-HER2 treatment must not have started more than 28 days before study entry.
• No prior chemotherapy or HER2-directed therapy for metastatic or locally advanced disease, prior therapy for early breast cancer (eBC) is allowed
• Signed informed consent prior to onset of documentation.

You may not qualify if:

• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (37)

Klinikum für Frauenheilkunde und Geburtshilfe Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Onkologische Schwerpunktpraxis Heidelberg

Heidelberg, Baden-Wurttemberg, 50937, Germany

Location

NCT Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Frauenklinik des Städtischen Klinikums

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

St. Vicentius Kliniken Karlsruhe gAG Frauenklininik

Karlsruhe, Baden-Wurttemberg, 76135, Germany

Location

Ortenau Klinikum Lahr-Ettenheim

Lahr, Baden-Wurttemberg, 77993, Germany

Location

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Klinikum Mannheim, Universitäts-Frauenklinik

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitätsfrauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Onkokom GbR

Altötting, Bavaria, 84503, Germany

Location

MVZ Amberg

Amberg, Bavaria, 92224, Germany

Location

Klinikum Augsburg Frauenklinik

Augsburg, Bavaria, 86156, Germany

Location

Rottal-Inn-Kliniken GmbH

Eggenfelden, Bavaria, 84307, Germany

Location

Universitätsfrauenklinik Erlangen

Erlangen, Bavaria, 91012, Germany

Location

Hämatologisch-Onkologische Praxis

Kronach, Bavaria, 96317, Germany

Location

Klinikum Nürnberg AöR

Nuremberg, Bavaria, 90419, Germany

Location

Hochschulklinikum der Med. Hochschule Brandenburg

Neuruppin, Brandenburg, 16816, Germany

Location

g.SUND Gynäkologie Kompetenzzentrum

Stralsund, Brandenburg, 18435, Germany

Location

Klinikum Darmstadt, Frauenklinik

Darmstadt, Hesse, 64283, Germany

Location

Zentrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Location

MVZ Onkologische Kooperation Harz Onkologische Schwerpunktpraxis

Goslar, Hesse, 38643, Germany

Location

Frauenklinik Wetzlar

Wetzlar, Hesse, 35578, Germany

Location

Agaplesion Diakonieklinikum Rotenburg/Wümme gGmbH

Rotenburg (Wümme), Lower Saxony, 27356, Germany

Location

Gemeinschaftspraxis f. Hämatologie u. Onkologie

Westerstede, Lower Saxony, 26655, Germany

Location

Facharztzentrum am Schloß

Wolfenbüttel, Lower Saxony, 38307, Germany

Location

MarienHospital Onkologische Praxis

Bonn, North Rhine-Westphalia, 53115, Germany

Location

Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, 46236, Germany

Location

Institut für Versorgungsforschung in der Onkologie

Cologne, North Rhine-Westphalia, 50679, Germany

Location

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe des Universitätsklinikums Köln Brustzentrum

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

Location

Klinikum Chemnitz gGmbH Frauenklinik

Chemnitz, Saxony, 09116, Germany

Location

Onkologische Gemeinschaftspraxis Dresden

Dresden, Saxony, 01307, Germany

Location

Universitäres Krebszentrum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Gemeinschaftspraxis

Halle, Saxony-Anhalt, 06110, Germany

Location

MediOnko-Institut GbT

Berlin, 10367, Germany

Location

Onkologisch-Hämatologische Schwerpunktpraxis

Bremen, 28209, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Diethelm Wallwiener, Prof. Dr.

  Universitätsfrauenklinik Tübingen

  STUDY DIRECTOR

• Peter Fasching, Prof. Dr.

  Frauenklinik des Universitätsklinikums Erlangen

  PRINCIPAL INVESTIGATOR

• Sara Brucker, Prof. Dr.

  Universitätsklinikum Tübingen Universitäts-Frauenklinik

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 30, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

DE (37)