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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02642458
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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.


Condition or disease
Metastatic Breast Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients: A Cohort Study of Patients Treated Either With Docetaxel and Trastuzumab or Docetaxel, Trastuzumab and Pertuzumab
Study Start Date : March 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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.



Primary Outcome Measures :
  1. progression free survival rate [ Time Frame: At 12 months or month 36 ]
    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.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Timepoint of progression or month 36 ]
    Progression free survival (PFS) is defined as the time interval from start of therapy until progression proven with clinical measures according to expertise and daily clinical routine or death from any cause, whichever comes first.

  2. Overall response rate [ Time Frame: Timepoint of progression or month 36 ]
    Overall response rate (ORR): Rate of complete (CR) and partial responses (PR) in patients. Response to treatment (CR, PR, SD, and PD) will be assessed by the treating physician and evaluated according to expertise and daily clinical routine. Underlying method of response assessment will be captured.

  3. Quality of life (EORTC QLQ-C30) [ Time Frame: At 12 months ]
    Quality of life (QoL) will be assessed by the EORTC QLQ-C30 (Version 3.0) within the first 12 months of first line treatment either with docetaxel and trastuzumab or docetaxel, trastuzumab and pertuzumab. The minimum target return rate for PRO questionnaires is 70% defined as at least 70% of patients having completed the PRO questionnaires at all collection time points.

  4. Incidence of adverse events and serious adverse events will be documented [ Time Frame: up 36 month ]
    Incidence of adverse events and serious adverse events will be reported according to NCI Common Toxicity Criteria Version 4.03.

  5. Quality of life (EORTC QLQ-BR23) [ Time Frame: At 12 months ]
    Quality of life (QoL) will be assessed by the EORTC QLQ-BR23 (Version 1.0) within the first 12 months of first line treatment either with docetaxel and trastuzumab or docetaxel, trastuzumab and pertuzumab. The minimum target return rate for PRO questionnaires is 70% defined as at least 70% of patients having completed the PRO questionnaires at all collection time points.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642458


Locations
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Germany
Klinikum für Frauenheilkunde und Geburtshilfe Esslingen
Esslingen, Baden-Württemberg, Germany, 73730
Onkologische Schwerpunktpraxis Heidelberg
Heidelberg, Baden-Württemberg, Germany, 50937
NCT Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Frauenklinik des Städtischen Klinikums
Karlsruhe, Baden-Württemberg, Germany, 76133
St. Vicentius Kliniken Karlsruhe gAG Frauenklininik
Karlsruhe, Baden-Württemberg, Germany, 76135
Ortenau Klinikum Lahr-Ettenheim
Lahr, Baden-Württemberg, Germany, 77993
Praxisklinik am Rosengarten
Mannheim, Baden-Württemberg, Germany, 68165
Klinikum Mannheim, Universitäts-Frauenklinik
Mannheim, Baden-Württemberg, Germany, 68167
Universitätsfrauenklinik Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Onkokom GbR
Altötting, Bayern, Germany, 84503
MVZ Amberg
Amberg, Bayern, Germany, 92224
Klinikum Augsburg Frauenklinik
Augsburg, Bayern, Germany, 86156
Rottal-Inn-Kliniken GmbH
Eggenfelden, Bayern, Germany, 84307
Universitätsfrauenklinik Erlangen
Erlangen, Bayern, Germany, 91012
Hämatologisch-Onkologische Praxis
Kronach, Bayern, Germany, 96317
Klinikum Nürnberg AöR
Nürnberg, Bayern, Germany, 90419
Hochschulklinikum der Med. Hochschule Brandenburg
Neuruppin, Brandenburg, Germany, 16816
g.SUND Gynäkologie Kompetenzzentrum
Stralsund, Brandenburg, Germany, 18435
Klinikum Darmstadt, Frauenklinik
Darmstadt, Hessen, Germany, 64283
Zentrum für Hämatologie und Onkologie Bethanien
Frankfurt, Hessen, Germany, 60389
MVZ Onkologische Kooperation Harz Onkologische Schwerpunktpraxis
Goslar, Hessen, Germany, 38643
Frauenklinik Wetzlar
Wetzlar, Hessen, Germany, 35578
Agaplesion Diakonieklinikum Rotenburg/Wümme gGmbH
Rotenburg, Niedersachsen, Germany, 27356
Gemeinschaftspraxis f. Hämatologie u. Onkologie
Westerstede, Niedersachsen, Germany, 26655
Facharztzentrum am Schloß
Wolfenbüttel, Niedersachsen, Germany, 38307
MarienHospital Onkologische Praxis
Bonn, Nordrhein-Westfalen, Germany, 53115
Marienhospital Bottrop gGmbH
Bottrop, Nordrhein-Westfalen, Germany, 46236
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45147
Institut für Versorgungsforschung in der Onkologie
Köln, Nordrhein-Westfalen, Germany, 50679
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe des Universitätsklinikums Köln Brustzentrum
Köln, Nordrhein-Westfalen, Germany, 50937
Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle
Kaiserslautern, Rheinland-Pfalz, Germany, 67655
Gemeinschaftspraxis
Halle (Saale), Sachsen-Anhalt, Germany, 06110
Klinikum Chemnitz gGmbH Frauenklinik
Chemnitz, Sachsen, Germany, 09116
Onkologische Gemeinschaftspraxis Dresden
Dresden, Sachsen, Germany, 01307
Universitäres Krebszentrum Leipzig
Leipzig, Sachsen, Germany, 04103
MediOnko-Institut GbT
Berlin, Germany, 10367
Onkologisch-Hämatologische Schwerpunktpraxis
Bremen, Germany, 28209
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Study Director: Diethelm Wallwiener, Prof. Dr. Universitätsfrauenklinik Tübingen
Principal Investigator: Peter Fasching, Prof. Dr. Frauenklinik des Universitätsklinikums Erlangen
Study Director: Sara Brucker, Prof. Dr. Universitätsklinikum Tübingen Universitäts-Frauenklinik

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02642458     History of Changes
Other Study ID Numbers: SEN2015-02
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological