First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
PERFORM
PERFORM: An EPidEmiological, PRospective Cohort Study to Generate Real-world Evidence in Patients With HR+/HER2- Advanced Breast Cancer Treated in the First Line Setting as Per Current Standard Of Care With an EndocRine-based Palbociclib CoMbination Therapy
2 other identifiers
observational
1,407
2 countries
192
Brief Summary
This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
January 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
April 13, 2026
April 1, 2026
7.4 years
January 21, 2021
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
from date of start of first-line treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 7.5 years
Secondary Outcomes (17)
Cohort-specific PFS of second-line treatment
from date of start of second-line treatment until the date of first subsequent documented disease progression or date of death from any cause, whichever came first, assessed up to 7.5 years
Cohort-specific PFS2
from date of start of first-line treatment until the date of documented disease progression on the respective second-line treatment or date of death from any cause, whichever came first, assessed up to 7.5 years
Landmark progression-free survival rates (PFSR) of first- and second-line treatment
proportion of patients without documented disease progression or death due to any cause at defined intervals after start of first-/second-line treatment (at 6, 12, 18, 24, 30, 36 months)
Overall survival (OS)
from date of start of first-line treatment until the date of documented death from any cause, assessed up to 7.5 years
Landmark overall survival rates (OSR)
proportion of patients without documented death due to any cause at defined intervals (at 12, 24, 36, 48, 60 months after start of first-line treatment)
- +12 more secondary outcomes
Study Arms (1)
First-line Palbociclib + endocrine therapy
Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Diagnosis of HR+/HER2- locally advanced, inoperable or metastatic breast cancer.
- 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.
- 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.
- Age of 18 years or older.
- Patients meeting any of the following criteria will not be included in the study:
- Any contraindication as per current local product label.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (192)
Sankt Josef Hospital Braunau
Braunau am Inn, 5280, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020, Austria
Country Hospital Salzburg
Salzburg, 5020, Austria
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100, Austria
Priv. Doz. OA Dr. Michael Hubalek
Schwaz, 6130, Austria
Medizinische Universität Wien, Abteilung Innere Medizin I
Vienna, 1090, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Oesterreichische Gesundheitskasse Hanusch-Krankenhaus
Vienna, 1140, Austria
Klinikum Bayreuth GmbH
Bayreuth, Bavaria, 95445, Germany
Klinikum Nürnberg
Nuremberg, Bavaria, 90419, Germany
Medizinische Universität Lausitz Carl Thiem
Cottbus, Brandenburg, 03048, Germany
Onkologische Kooperation Harz
Goslar, Lower Saxony, 38642, Germany
Johanniter-MVZ Bonn GmbH
Bonn, North Rhine-Westphalia, 53113, Germany
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, Other, 97980, Germany
Mvz Etgo Gmbh
Berlin, Other, 12107, Germany
Onkologisch-Hämatologische Schwerpunktpraxis
Bremen, Other, 28209, Germany
ANregiomed gKU
Ansbach, 91522, Germany
Alexianer Klinikum Hochsauerland GmbH
Arnsberg, 59759, Germany
Group practice Heinrich
Augsburg, 86150, Germany
Group Practice Steinfeld-Birg
Augsburg, 86150, Germany
Group practice Tanzer
Bad Reichenhall, 83435, Germany
Group practice Seipelt
Bad Soden a.T., 65812, Germany
Klinikum Mittelbaden Baden-Baden Balg
Baden-Baden, 76532, Germany
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, 96049, Germany
Private Practice Bayreuth
Bayreuth, 95445, Germany
Charité Campus Mitte
Berlin, 10117, Germany
Hämatologie Onkologie Berlin-Mitte
Berlin, 10117, Germany
MediOnko-Institut GbR
Berlin, 10367, Germany
DRK Kliniken Berlin-Köpenick Brustzentrum
Berlin, 12559, Germany
Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf
Berlin, 12683, Germany
Group practice Morack
Berlin, 13156, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 13407, Germany
Frauenarzt-Zentrum-Zehlendorf
Berlin, 14169, Germany
Dr. Leonid Basovski Hämatologikum Biberach
Biberach an der Riss, 85400, Germany
Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie
Bielefeld, 33617, Germany
Group practice Bueckner
Bochum, 44787, Germany
Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR
Bonn, 53123, Germany
Group practice Hannig
Bottrop, 46236, Germany
Marienhospital Bottrop gGmbH
Bottrop, 46236, Germany
ONKO DOK GbR
Bottrop, 46236, Germany
Kliniken Boeblingen
Böblingen, 71032, Germany
Private practice Brandenburg a.d.H.
Brandenburg a.d.H., 14770, Germany
Staedtisches Klinikum Brandenburg GmbH
Brandenburg an der Havel, 14770, Germany
Klinikum Bremerhaven Reinkenheide gGmbH
Bremerhaven, 27574, Germany
Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe
Bruchsal, 76646, Germany
AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH
Celle, 29223, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Private Practice Jungberg
Chemnitz, 09117, Germany
private practice Ziegler-Loehr
Cologne, 50679, Germany
St. Elisabeth Krankenhaus GmbH
Cologne, 50935, Germany
St. Vincenz-Krankenhaus
Datteln, 45711, Germany
Onkologiezentrum Donauwoerth
Donauwörth, 86609, Germany
Klinikum Dortmund Frauenklinik
Dortmund, 44137, Germany
Studiengesellschaft Gefos Dortmund mbH
Dortmund, 44263, Germany
Group practice Goehler
Dresden, 01127, Germany
Gemeinschaftspraxis
Dresden, 01307, Germany
Group practice Jacobasch
Dresden, 01307, Germany
Naedler GmbH
Duisburg, 47166, Germany
St. Marien-Hospital
Düren, 52353, Germany
Private Practice Groell
Ebersberg, 85560, Germany
Studienzentrale für das MVZ Eggenfelde e.K.
Eggenfelden, 84307, Germany
St. Georg Klinikum Eisenach gGmbH
Eisenach, 99817, Germany
Group practice Weniger
Erfurt, 99085, Germany
Group practice Haecker
Erlangen, 91052, Germany
imland gGmbH
Fockbek, 24787, Germany
Universitaetsklinikum Frankfurt Frauenheilkunde
Frankfurt am Main, 60590, Germany
pioh Studien und Management GbR
Frechen, 50226, Germany
Group Practice Dr. med. M. Zaiss
Freiburg im Breisgau, 79110, Germany
KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe
Freudenstadt, 72250, Germany
Group practice Fuerth
Fürth, 90766, Germany
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, 49124, Germany
Onkostudien Gera GbR
Gera, 07548, Germany
Private practice Rabenbauer
Grafenau, 94481, Germany
Klinikum Oberberg KKH Gummersbach
Gummersbach, 51643, Germany
Onkodok GmbH
Gütersloh, 33332, Germany
Group practice Neumeister
Haldensleben I, 39340, Germany
Group practice Behlendorf
Halle, 06110, Germany
Studiengesellschaft Haemato-Onkologie Hamburg GbR
Hamburg, 20251, Germany
Praxisklinik Harburger Ring
Hamburg, 21073, Germany
Katholisches Marienkrankenhaus gGmbH Frauenklinik
Hamburg, 22087, Germany
Überörtliche Gemeinschaftspraxis
Hamburg, 48415, Germany
Private Practice Rubanov
Hamelin, 31785, Germany
Klinikum Hanau Gynäkologisches Krebszentrum
Hanau, 63450, Germany
Group Practice Kamal
Hanover, 30625, Germany
Westkuestenkliniken Heide und Brunsbuettel
Heide, 25746, Germany
Private Practice Fuxius
Heidelberg, 69115, Germany
Private practice Petersen
Heidenheim a.d.B., 89522, Germany
Mathilden-Hospital
Herford, 32052, Germany
cancer Center Zweiseenland GbR
Herrsching am Ammersee, 82211, Germany
Private Practice Dr. med. Andreas Lorenz
Hildburghausen, 98646, Germany
Gemeinschaftspraxis Dr.med. Ch. Uleer
Hildesheim, 31134, Germany
Onkologie Hof MVZ GmbH
Hof, 95028, Germany
Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,
Homberg (Efze), 66421, Germany
Frauenarzt Toralf Baerens
Ilsede, 31241, Germany
Klinikum Itzehoe
Itzehoe, 25524, Germany
IDGGQ GbR
Kaiserslautern, 67655, Germany
ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, 76135, Germany
Diakonissenkrankenhaus Karlsruhe
Karlsruhe, 76199, Germany
Klinikum Kaufbeuren
Kaufbeuren, 87600, Germany
Institut fuer Versorgungsforschung in der Onkologie GbR
Koblenz, 56068, Germany
Klinikum Dahme-Spreewald GmbH
Königs Wusterhausen, 15711, Germany
group practice Krefeld
Krefeld, 47805, Germany
Private practice Kronach
Kronach, 96317, Germany
Klinikum Kulmbach
Kulmbach, 95326, Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut
Landshut, 84036, Germany
Group practice Koehler
Langen, 63225, Germany
Onkologisches Zentrum Lebach
Lebach, 66822, Germany
Group practice Mueller
Leer, 26789, Germany
Group practice Knoblich
Loerrach, 79539, Germany
Private practice Wierick
Lohsa, 02999, Germany
Universitätsklinikum Schleswig Holstein
Lübeck, 23538, Germany
Onkologie Zentrum Lüneburg Praxisgemeinschaft
Lüneburg, 21335, Germany
Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum
Magdeburg, 39108, Germany
Klinikum Magdeburg Frauenheilkunde und Geburtshilfe
Magdeburg, 39130, Germany
Group practice Prof. Dr. M. Hensel
Mannheim, 63739, Germany
Klinikum Fichtelgebirge gGmbH
Marktredwitz, 95615, Germany
Hämatologisch Onkologisches Studieninstitut
Mayen, 56727, Germany
MVZ Hämatologie/Onkologie
Mayen, 56727, Germany
OnkoLog Moers GbR
Moers, 47441, Germany
Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, 41061, Germany
Stauferklinikum Schwaebisch Gmuend
Mutlangen, 73557, Germany
MVZ GmbH-Muehlhausen
Mühlhausen, 99974, Germany
Onko - Log Muelheim GbR
Mühlheim, 45468, Germany
Klinikum Dritter Orden
München, 80638, Germany
Group practice Schmidt
München, 81241, Germany
Private practice Naunhof
Naunhof, 04683, Germany
Dr Ines Vanselor Gessner U A Kagelmacher
Neubrandenburg, 17036, Germany
Group Practice Nacke
Neuenahr-Ahrweller, 53474, Germany
Friedrich-Ebert-Krankenhaus
Neumünster, 24534, Germany
TZN-Tumorzentrum Niederrhein GmbH
Neuss, 41462, Germany
Spital 2 medizinisches Institut PartG mbB
Nuremberg, 90403, Germany
medius Klinik Nürtingen
Nürtingen, 72622, Germany
ONSO GbR
Oldenburg, 26121, Germany
Pius Hospital Oldenburg
Oldenburg, 26121, Germany
Oberhavel Kliniken GmbH
Oranienburg, 16515, Germany
Klinikum Osnabrueck GmbH
Osnabrück, 49076, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, 14467, Germany
MVZ für Hämatologie und Onkologie
Ravensburg, 88212, Germany
Oncologianova GmbH
Recklinghausen, 45659, Germany
Group practice Remscheid
Remscheid, 42853, Germany
Private practice Remscheid
Remscheid, 42853, Germany
Onkologie Zentrum Süd MVZ GmbH
Remscheid, 42859, Germany
Gemeinschaftspraxis für internistische Hämatologie und Onkologie
Rheine, 12489, Germany
Nadler GmbH
Rinteln, 31737, Germany
Private practice Markmann
Rostock, 18057, Germany
Klinikum Suedstadt Rostock, Universitaetsfrauenklinik
Rostock, 18059, Germany
Agaplesion Diakonieklinik Rotenburg gGmbH
Rotenburg (Wümme), 27356, Germany
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, 65428, Germany
CaritasKlinikum St. Theresia
Saarbrücken, 66113, Germany
Krankenhaus Saarlouis vom DRK
Saarlouis, 66740, Germany
Private practice Schubert
Scheibenberg, 09481, Germany
MedCenter Nordsachsen - Studien
Schkeuditz, 04435, Germany
Onkster GbR
Schorndorf, 73614, Germany
Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH
Schwäbisch Hall, 74523, Germany
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Schweinfurt, 97422, Germany
Marienkrankenhaus Schwerte
Schwerte, 58239, Germany
Group Practice Esser
Siegburg, 53721, Germany
Group practice Singen
Singen (Hohentwiel), 78224, Germany
Onkologiezentrum Soest/Iserlohn
Soest, 59494, Germany
Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde
Solingen, 42653, Germany
KMG Klinikum Sömmerda
Sömmerda, 99610, Germany
Group practice Behringer
Speyer, 67346, Germany
MVZ Klinik Dr. Hancken GmbH
Stade, 21680, Germany
Johanniter-Krankenhaus Genthin Stendal
Stendal, 39576, Germany
Private Practice Denck
Stendal, 39576, Germany
Clinical Research Stohlberg GmbH
Stohlberg, 52222, Germany
Private practice Stralsund
Stralsund, 18435, Germany
Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
Stralsund, 18439, Germany
Klinikum der Landeshauptstadt Stuttgart gKAoeR
Stuttgart, 70174, Germany
Vinzenz von Paul Kliniken gGmbH Marienhospital
Stuttgart, 70199, Germany
Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl
Suhl, 98527, Germany
SRH Zentralklinikum Suhl GmbH
Suhl, 98527, Germany
Group Practice Kronawitter
Traunstein, 83278, Germany
Klinikum Traunstein
Traunstein, 83278, Germany
Group practice Forstbauer
Troisdorf, 53840, Germany
Private practice Weissenborn
Twistringen, 27239, Germany
Group practice Wagner
Völklingen, 66333, Germany
GRN Klinik Weinheim
Weinheim, 69469, Germany
Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum
Weißenfels, 06667, Germany
MVZ Marien-Hospital Wesel GmbH
Wesel, 46483, Germany
Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, 26655, Germany
Lahn-Dill-Kliniken GmbH
Wetzlar, 35578, Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199, Germany
Gruop practice Rodemer / Wismann / Distelrath
Wilhelmshaven, 26389, Germany
Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe
Winnenden, 71364, Germany
GIM - Gemeinschaftspraxis Innere Medizin
Witten, 58452, Germany
Group practice Wolfsburg
Wolfsburg, 38440, Germany
Helios Universitätsklinikum Wuppertal GmbH
Wuppertal, 42283, Germany
Group practice Wuerzburg
Würzburg, 97080, Germany
Universitätsklinikum Wuerzburg AoeR
Würzburg, 97080, Germany
Related Publications (1)
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.
PMID: 36427183DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2021
First Posted
February 23, 2021
Study Start
October 27, 2020
Primary Completion (Estimated)
April 3, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.