First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

NCT ID: NCT04767594

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1409 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2029-04-30

Brief Summary

This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.

Detailed Description

Patients diagnosed with HR+/HER2- locally advanced or metastatic breast cancer indicated by their treating physicians for first line endocrine-based palbociclib combination therapy and who meet eligibility criteria will be invited to participate in this study. The key objectives of this study are to describe clinical, scientific and patient reported outcomes for patients with HR+/HER2- locally advanced or metastatic breast cancer initiating treatment with first line endocrine-based palbociclib combination therapy in the real-world setting in Germany and Austria. Patient characteristics, real-world treatment patterns, treatment sequences and reasons for the physician's treatment decisions will be collected. Additional real-world research questions are to explore patient-focused parameters such as longitudinal follow-up data on patient-reported outcomes beyond disease progression and by treatment sequence or to analyze the time from the start of first line treatment to the first administered palliative chemotherapy. Clinical outcome by treatment sequences will be described. Routinely assessed biomarkers and diagnostic procedures applied for treatment sequence decisions will be collected.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First-line Palbociclib + endocrine therapy

Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy

Palbociclib + endocrine therapy

Intervention Type: DRUG

Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Interventions

Palbociclib + endocrine therapy

Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

2. Diagnosis of HR+/HER2- locally advanced, inoperable or metastatic breast cancer.

3. Physician has determined that first-line treatment with palbociclib (i) in combination with an aromatase inhibitor, or (ii) in combination with fulvestrant in women who received prior endocrine therapy as per current local product label is indicated. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

4. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per local standard of care practice at the study site.

5. Age of 18 years or older.

Patients meeting any of the following criteria will not be included in the study:

1. Any contraindication as per current local product label.

2. Prior systemic antineoplastic treatment for advanced disease. Exception: Start of first line treatment with palbociclib in combination with aromatase inhibitor or fulvestrant as per current local product label is allowed up to 4 weeks prior to inclusion.

3. Patients currently participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. Note: A concomitant participation in other non-interventional/observational studies, registries and translational research networks (e.g., PRAEGNANT, OPAL) or chart reviews is allowed.

4. Patients who are unable to understand the nature of the study or are unwilling to sign an informed consent.

Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Sankt Josef Hospital Braunau

Braunau am Inn, , Austria

Medizinische Universität Innsbruck

Innsbruck, , Austria

Klinikum Klagenfurt am Woerthersee

Klagenfurt, , Austria

Country Hospital Salzburg

Salzburg, , Austria

Universitaetsklinikum Sankt Poelten

Sankt Pölten, , Austria

Priv. Doz. OA Dr. Michael Hubalek

Schwaz, , Austria

Medizinische Universität Wien, Abteilung Innere Medizin I

Vienna, , Austria

Medizinische Universität Wien

Vienna, , Austria

Oesterreichische Gesundheitskasse Hanusch-Krankenhaus

Vienna, , Austria

Klinikum Bayreuth GmbH

Bayreuth, Bavaria, Germany

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Medizinische Universität Lausitz Carl Thiem

Cottbus, Brandenburg, Germany

Onkologische Kooperation Harz

Goslar, Lower Saxony, Germany

Caritas-Krankenhaus Bad Mergentheim

Bad Mergentheim, Other, Germany

Mvz Etgo Gmbh

Berlin, Other, Germany

Onkologisch-Hämatologische Schwerpunktpraxis

Bremen, Other, Germany

ANregiomed gKU

Ansbach, , Germany

Alexianer Klinikum Hochsauerland GmbH

Arnsberg, , Germany

Group practice Heinrich

Augsburg, , Germany

Group Practice Steinfeld-Birg

Augsburg, , Germany

Group practice Tanzer

Bad Reichenhall, , Germany

Group practice Seipelt

Bad Soden a.T., , Germany

Klinikum Mittelbaden Baden-Baden Balg

Baden-Baden, , Germany

Sozialstiftung Bamberg Klinikum am Bruderwald

Bamberg, , Germany

Private Practice Bayreuth

Bayreuth, , Germany

Charité Campus Mitte

Berlin, , Germany

Hämatologie Onkologie Berlin-Mitte

Berlin, , Germany

MediOnko-Institut GbR

Berlin, , Germany

DRK Kliniken Berlin-Köpenick Brustzentrum

Berlin, , Germany

Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf

Berlin, , Germany

Group practice Morack

Berlin, , Germany

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Frauenarzt-Zentrum-Zehlendorf

Berlin, , Germany

Dr. Leonid Basovski Hämatologikum Biberach

Biberach an der Riss, , Germany

Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie

Bielefeld, , Germany

Group practice Bueckner

Bochum, , Germany

Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR

Bonn, , Germany

Group practice Hannig

Bottrop, , Germany

Marienhospital Bottrop gGmbH

Bottrop, , Germany

ONKO DOK GbR

Bottrop, , Germany

Kliniken Boeblingen

Böblingen, , Germany

Staedtisches Klinikum Brandenburg GmbH

Brandenburg, , Germany

Private practice Brandenburg a.d.H.

Brandenburg a.d.H., , Germany

Klinikum Bremerhaven Reinkenheide gGmbH

Bremerhaven, , Germany

Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe

Bruchsal, , Germany

AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH

Celle, , Germany

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Private Practice Jungberg

Chemnitz, , Germany

private practice Ziegler-Loehr

Cologne, , Germany

St. Elisabeth Krankenhaus GmbH

Cologne, , Germany

St. Vincenz-Krankenhaus

Datteln, , Germany

Onkologiezentrum Donauwoerth

Donauwörth, , Germany

Klinikum Dortmund Frauenklinik

Dortmund, , Germany

Studiengesellschaft Gefos Dortmund mbH

Dortmund, , Germany

Group practice Goehler

Dresden, , Germany

Gemeinschaftspraxis

Dresden, , Germany

Group practice Jacobasch

Dresden, , Germany

Naedler GmbH

Duisburg, , Germany

St. Marien-Hospital

Düren, , Germany

Private Practice Groell

Ebersberg, , Germany

Studienzentrale für das MVZ Eggenfelde e.K.

Eggenfelden, , Germany

St. Georg Klinikum Eisenach gGmbH

Eisenach, , Germany

Group practice Weniger

Erfurt, , Germany

Group practice Haecker

Erlangen, , Germany

imland gGmbH

Fockbek, , Germany

Universitaetsklinikum Frankfurt Frauenheilkunde

Frankfurt am Main, , Germany

pioh Studien und Management GbR

Frechen, , Germany

Group Practice Dr. med. M. Zaiss

Freiburg im Breisgau, , Germany

KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe

Freudenstadt, , Germany

Group practice Fuerth

Fürth, , Germany

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, , Germany

Onkostudien Gera GbR

Gera, , Germany

Private practice Rabenbauer

Grafenau, , Germany

Klinikum Oberberg KKH Gummersbach

Gummersbach, , Germany

Onkodok GmbH

Gütersloh, , Germany

Group practice Neumeister

Haldensleben I, , Germany

Group practice Behlendorf

Halle, , Germany

Studiengesellschaft Haemato-Onkologie Hamburg GbR

Hamburg, , Germany

Praxisklinik Harburger Ring

Hamburg, , Germany

Katholisches Marienkrankenhaus gGmbH Frauenklinik

Hamburg, , Germany

Überörtliche Gemeinschaftspraxis

Hamburg, , Germany

Private Practice Rubanov

Hamelin, , Germany

Klinikum Hanau Gynäkologisches Krebszentrum

Hanau, , Germany

Group Practice Kamal

Hanover, , Germany

Westkuestenkliniken Heide und Brunsbuettel

Heide, , Germany

Private Practice Fuxius

Heidelberg, , Germany

Private practice Petersen

Heidenheim a.d.B., , Germany

Mathilden-Hospital

Herford, , Germany

cancer Center Zweiseenland GbR

Herrsching am Ammersee, , Germany

Private Practice Dr. med. Andreas Lorenz

Hildburghausen, , Germany

Gemeinschaftspraxis Dr.med. Ch. Uleer

Hildesheim, , Germany

Onkologie Hof MVZ GmbH

Hof, , Germany

Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,

Homberg (Efze), , Germany

Frauenarzt Toralf Baerens

Ilsede, , Germany

Klinikum Itzehoe

Itzehoe, , Germany

IDGGQ GbR

Kaiserslautern, , Germany

ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, , Germany

Diakonissenkrankenhaus Karlsruhe

Karlsruhe, , Germany

Klinikum Kaufbeuren

Kaufbeuren, , Germany

Institut fuer Versorgungsforschung in der Onkologie GbR

Koblenz, , Germany

Klinikum Dahme-Spreewald GmbH

Königs Wusterhausen, , Germany

group practice Krefeld

Krefeld, , Germany

Private practice Kronach

Kronach, , Germany

Klinikum Kulmbach

Kulmbach, , Germany

ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut

Landshut, , Germany

Group practice Koehler

Langen, , Germany

Onkologisches Zentrum Lebach

Lebach, , Germany

Group practice Mueller

Leer, , Germany

Group practice Knoblich

Loerrach, , Germany

Private practice Wierick

Lohsa, , Germany

Universitätsklinikum Schleswig Holstein

Lübeck, , Germany

Onkologie Zentrum Lüneburg Praxisgemeinschaft

Lüneburg, , Germany

Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum

Magdeburg, , Germany

Klinikum Magdeburg Frauenheilkunde und Geburtshilfe

Magdeburg, , Germany

Group practice Prof. Dr. M. Hensel

Mannheim, , Germany

Klinikum Fichtelgebirge gGmbH

Marktredwitz, , Germany

Hämatologisch Onkologisches Studieninstitut

Mayen, , Germany

MVZ Hämatologie/Onkologie

Mayen, , Germany

OnkoLog Moers GbR

Moers, , Germany

Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH

Mönchengladbach, , Germany

Stauferklinikum Schwaebisch Gmuend

Mutlangen, , Germany

MVZ GmbH-Muehlhausen

Mühlhausen, , Germany

Onko - Log Muelheim GbR

Mühlheim, , Germany

Klinikum Dritter Orden

München, , Germany

Group practice Schmidt

München, , Germany

Private practice Naunhof

Naunhof, , Germany

Dr Ines Vanselor Gessner U A Kagelmacher

Neubrandenburg, , Germany

Group Practice Nacke

Neuenahr-Ahrweller, , Germany

Friedrich-Ebert-Krankenhaus

Neumünster, , Germany

TZN-Tumorzentrum Niederrhein GmbH

Neuss, , Germany

Spital 2 medizinisches Institut PartG mbB

Nuremberg, , Germany

medius Klinik Nürtingen

Nürtingen, , Germany

ONSO GbR

Oldenburg, , Germany

Pius Hospital Oldenburg

Oldenburg, , Germany

Oberhavel Kliniken GmbH

Oranienburg, , Germany

Klinikum Osnabrueck GmbH

Osnabrück, , Germany

St. Vincenz-Krankenhaus GmbH

Paderborn, , Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, , Germany

MVZ für Hämatologie und Onkologie

Ravensburg, , Germany

Oncologianova GmbH

Recklinghausen, , Germany

Group practice Remscheid

Remscheid, , Germany

Private practice Remscheid

Remscheid, , Germany

Onkologie Zentrum Süd MVZ GmbH

Remscheid, , Germany

Gemeinschaftspraxis für internistische Hämatologie und Onkologie

Rheine, , Germany

Nadler GmbH

Rinteln, , Germany

Private practice Markmann

Rostock, , Germany

Klinikum Suedstadt Rostock, Universitaetsfrauenklinik

Rostock, , Germany

Agaplesion Diakonieklinik Rotenburg gGmbH

Rotenburg (Wümme), , Germany

GPR Klinikum Rüsselsheim

Rüsselsheim am Main, , Germany

CaritasKlinikum St. Theresia

Saarbrücken, , Germany

Krankenhaus Saarlouis vom DRK

Saarlouis, , Germany

Private practice Schubert

Scheibenberg, , Germany

MedCenter Nordsachsen - Studien

Schkeuditz, , Germany

Onkster GbR

Schorndorf, , Germany

Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH

Schwäbisch Hall, , Germany

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

Schweinfurt, , Germany

Marienkrankenhaus Schwerte

Schwerte, , Germany

Group Practice Esser

Siegburg, , Germany

Group practice Singen

Singen (Hohentwiel), , Germany

Onkologiezentrum Soest/Iserlohn

Soest, , Germany

Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde

Solingen, , Germany

KMG Klinikum Sömmerda

Sömmerda, , Germany

Group practice Behringer

Speyer, , Germany

MVZ Klinik Dr. Hancken GmbH

Stade, , Germany

Johanniter-Krankenhaus Genthin Stendal

Stendal, , Germany

Private Practice Denck

Stendal, , Germany

Clinical Research Stohlberg GmbH

Stohlberg, , Germany

Private practice Stralsund

Stralsund, , Germany

Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher

Stralsund, , Germany

Klinikum der Landeshauptstadt Stuttgart gKAoeR

Stuttgart, , Germany

Vinzenz von Paul Kliniken gGmbH Marienhospital

Stuttgart, , Germany

Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl

Suhl, , Germany

SRH Zentralklinikum Suhl GmbH

Suhl, , Germany

Group Practice Kronawitter

Traunstein, , Germany

Klinikum Traunstein

Traunstein, , Germany

Group practice Forstbauer

Troisdorf, , Germany

Private practice Weissenborn

Twistringen, , Germany

Group practice Wagner

Völklingen, , Germany

GRN Klinik Weinheim

Weinheim, , Germany

Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum

Weißenfels, , Germany

MVZ Marien-Hospital Wesel GmbH

Wesel, , Germany

Medizinische Studiengesellschaft NORD-WEST GmbH

Westerstede, , Germany

Lahn-Dill-Kliniken GmbH

Wetzlar, , Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, , Germany

Gruop practice Rodemer / Wismann / Distelrath

Wilhelmshaven, , Germany

Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe

Winnenden, , Germany

GIM - Gemeinschaftspraxis Innere Medizin

Witten, , Germany

Group practice Wolfsburg

Wolfsburg, , Germany

Helios Universitätsklinikum Wuppertal GmbH

Wuppertal, , Germany

Group practice Wuerzburg

Würzburg, , Germany

Universitätsklinikum Wuerzburg AoeR

Würzburg, , Germany

Countries

Austria; Germany

References

Lux MP, Runkel ED, Glastetter E, Vannier C, Buncke J, Frank M, Bartsch R, Thill M, Wockel A. PERFORM: a non-interventional study assessing the patients' treatment starting with 1L palbociclib in HR+/HER2- ABC. Future Oncol. 2022 Nov;18(36):3971-3982. doi: 10.2217/fon-2022-0552. Epub 2022 Nov 25.

Reference Type: DERIVED

PMID: 36427183 (View on PubMed)

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A5481152

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Other Identifiers

PERFORM-NIS

Identifier Type: OTHER

Identifier Source: secondary_id

A5481152

Identifier Type: -

Identifier Source: org_study_id