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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Palbociclib + endocrine therapy

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.

• Study Type: Observational
• Enrollment (Actual): 1407

Contacts and Locations

Study Locations

• Austria
  • Braunau am Inn, Austria, 5280
    • Sankt Josef Hospital Braunau
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Woerthersee
  • Salzburg, Austria, 5020
    • Country Hospital Salzburg
  • Sankt Pölten, Austria, 3100
    • Universitaetsklinikum Sankt Poelten
  • Schwaz, Austria, 6130
    • Priv. Doz. OA Dr. Michael Hubalek
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien
  • Vienna, Austria, 1140
    • Oesterreichische Gesundheitskasse Hanusch-Krankenhaus
  • Vienna, Austria, 1090
    • Medizinische Universität Wien, Abteilung Innere Medizin I
• Germany
  • Ansbach, Germany, 91522
    • ANregiomed gKU
  • Arnsberg, Germany, 59759
    • Alexianer Klinikum Hochsauerland GmbH
  • Augsburg, Germany, 86150
    • Group practice Heinrich
  • Augsburg, Germany, 86150
    • Group Practice Steinfeld-Birg
  • Bad Reichenhall, Germany, 83435
    • Group practice Tanzer
  • Bad Soden a.T., Germany, 65812
    • Group practice Seipelt
  • Baden-Baden, Germany, 76532
    • Klinikum Mittelbaden Baden-Baden Balg
  • Bamberg, Germany, 96049
    • Sozialstiftung Bamberg Klinikum am Bruderwald
  • Bayreuth, Germany, 95445
    • Private Practice Bayreuth
  • Berlin, Germany, 10117
    • Charite Campus Mitte
  • Berlin, Germany, 14169
    • Frauenarzt-Zentrum-Zehlendorf
  • Berlin, Germany, 10367
    • MediOnko-Institut GbR
  • Berlin, Germany, 10117
    • Hämatologie Onkologie Berlin-Mitte
  • Berlin, Germany, 12559
    • DRK Kliniken Berlin-Köpenick Brustzentrum
  • Berlin, Germany, 12683
    • Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf
  • Berlin, Germany, 13156
    • Group practice Morack
  • Berlin, Germany, 13407
    • Vivantes Netzwerk für Gesundheit GmbH
  • Biberach an der Riss, Germany, 85400
    • Dr. Leonid Basovski Hämatologikum Biberach
  • Bielefeld, Germany, 33617
    • Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie
  • Bochum, Germany, 44787
    • Group practice Bueckner
  • Bonn, Germany, 53123
    • Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR
  • Bottrop, Germany, 46236
    • Marienhospital Bottrop gGmbH
  • Bottrop, Germany, 46236
    • Group practice Hannig
  • Bottrop, Germany, 46236
    • ONKO DOK GbR
  • Brandenburg a.d.H., Germany, 14770
    • Private practice Brandenburg a.d.H.
  • Brandenburg an der Havel, Germany, 14770
    • Staedtisches Klinikum Brandenburg GmbH
  • Bremerhaven, Germany, 27574
    • Klinikum Bremerhaven Reinkenheide gGmbH
  • Bruchsal, Germany, 76646
    • Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe
  • Böblingen, Germany, 71032
    • Kliniken Boeblingen
  • Celle, Germany, 29223
    • AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Chemnitz, Germany, 09117
    • Private Practice Jungberg
  • Cologne, Germany, 50679
    • private practice Ziegler-Loehr
  • Cologne, Germany, 50935
    • St. Elisabeth Krankenhaus GmbH
  • Datteln, Germany, 45711
    • St. Vincenz-Krankenhaus
  • Donauwörth, Germany, 86609
    • Onkologiezentrum Donauwoerth
  • Dortmund, Germany, 44137
    • Klinikum Dortmund Frauenklinik
  • Dortmund, Germany, 44263
    • Studiengesellschaft Gefos Dortmund mbH
  • Dresden, Germany, 01307
    • Gemeinschaftspraxis
  • Dresden, Germany, 01127
    • Group practice Goehler
  • Dresden, Germany, 01307
    • Group practice Jacobasch
  • Duisburg, Germany, 47166
    • Naedler GmbH
  • Düren, Germany, 52353
    • St. Marien-Hospital
  • Ebersberg, Germany, 85560
    • Private Practice Groell
  • Eggenfelden, Germany, 84307
    • Studienzentrale für das MVZ Eggenfelde e.K.
  • Eisenach, Germany, 99817
    • St. Georg Klinikum Eisenach gGmbH
  • Erfurt, Germany, 99085
    • Group practice Weniger
  • Erlangen, Germany, 91052
    • Group practice Haecker
  • Fockbek, Germany, 24787
    • imland gGmbH
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt Frauenheilkunde
  • Frechen, Germany, 50226
    • pioh Studien und Management GbR
  • Freiburg im Breisgau, Germany, 79110
    • Group Practice Dr. med. M. Zaiss
  • Freudenstadt, Germany, 72250
    • KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe
  • Fürth, Germany, 90766
    • Group practice Fuerth
  • Georgsmarienhütte, Germany, 49124
    • MVZ Ⅱ der Niels Stensen Kliniken
  • Gera, Germany, 07548
    • Onkostudien Gera GbR
  • Grafenau, Germany, 94481
    • Private practice Rabenbauer
  • Gummersbach, Germany, 51643
    • Klinikum Oberberg KKH Gummersbach
  • Gütersloh, Germany, 33332
    • Onkodok GmbH
  • Haldensleben I, Germany, 39340
    • Group practice Neumeister
  • Halle, Germany, 06110
    • Group practice Behlendorf
  • Hamburg, Germany, 48415
    • Überörtliche Gemeinschaftspraxis
  • Hamburg, Germany, 20251
    • Studiengesellschaft Haemato-Onkologie Hamburg GbR
  • Hamburg, Germany, 21073
    • Praxisklinik Harburger Ring
  • Hamburg, Germany, 22087
    • Katholisches Marienkrankenhaus gGmbH Frauenklinik
  • Hamelin, Germany, 31785
    • Private Practice Rubanov
  • Hanau, Germany, 63450
    • Klinikum Hanau Gynäkologisches Krebszentrum
  • Hanover, Germany, 30625
    • Group Practice Kamal
  • Heide, Germany, 25746
    • Westkuestenkliniken Heide und Brunsbuettel
  • Heidelberg, Germany, 69115
    • Private Practice Fuxius
  • Heidenheim a.d.B., Germany, 89522
    • Private practice Petersen
  • Herford, Germany, 32052
    • Mathilden-Hospital
  • Herrsching am Ammersee, Germany, 82211
    • cancer Center Zweiseenland GbR
  • Hildburghausen, Germany, 98646
    • Private Practice Dr. med. Andreas Lorenz
  • Hildesheim, Germany, 31134
    • Gemeinschaftspraxis Dr.med. Ch. Uleer
  • Hof, Germany, 95028
    • Onkologie Hof MVZ GmbH
  • Homberg (Efze), Germany, 66421
    • Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,
  • Ilsede, Germany, 31241
    • Frauenarzt Toralf Baerens
  • Itzehoe, Germany, 25524
    • Klinikum Itzehoe
  • Kaiserslautern, Germany, 67655
    • IDGGQ GbR
  • Karlsruhe, Germany, 76135
    • ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG
  • Karlsruhe, Germany, 76199
    • Diakonissenkrankenhaus Karlsruhe
  • Kaufbeuren, Germany, 87600
    • Klinikum Kaufbeuren
  • Koblenz, Germany, 56068
    • Institut fuer Versorgungsforschung in der Onkologie GbR
  • Krefeld, Germany, 47805
    • group practice Krefeld
  • Kronach, Germany, 96317
    • Private practice Kronach
  • Kulmbach, Germany, 95326
    • Klinikum Kulmbach
  • Königs Wusterhausen, Germany, 15711
    • Klinikum Dahme-Spreewald GmbH
  • Landshut, Germany, 84036
    • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut
  • Langen, Germany, 63225
    • Group practice Koehler
  • Lebach, Germany, 66822
    • Onkologisches Zentrum Lebach
  • Leer, Germany, 26789
    • Group practice Mueller
  • Loerrach, Germany, 79539
    • Group practice Knoblich
  • Lohsa, Germany, 02999
    • Private practice Wierick
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein
  • Lüneburg, Germany, 21335
    • Onkologie Zentrum Lüneburg Praxisgemeinschaft
  • Magdeburg, Germany, 39108
    • Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg Frauenheilkunde und Geburtshilfe
  • Mannheim, Germany, 63739
    • Group practice Prof. Dr. M. Hensel
  • Marktredwitz, Germany, 95615
    • Klinikum Fichtelgebirge gGmbH
  • Mayen, Germany, 56727
    • Hämatologisch Onkologisches Studieninstitut
  • Mayen, Germany, 56727
    • MVZ Hämatologie/Onkologie
  • Moers, Germany, 47441
    • OnkoLog Moers GbR
  • Mutlangen, Germany, 73557
    • Stauferklinikum Schwaebisch Gmuend
  • Mönchengladbach, Germany, 41061
    • Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH
  • Mühlhausen, Germany, 99974
    • MVZ GmbH-Muehlhausen
  • Mühlheim, Germany, 45468
    • Onko - Log Muelheim GbR
  • München, Germany, 80638
    • Klinikum Dritter Orden
  • München, Germany, 81241
    • Group practice Schmidt
  • Naunhof, Germany, 04683
    • Private practice Naunhof
  • Neubrandenburg, Germany, 17036
    • Dr Ines Vanselor Gessner U A Kagelmacher
  • Neuenahr-Ahrweller, Germany, 53474
    • Group Practice Nacke
  • Neumünster, Germany, 24534
    • Friedrich-Ebert-Krankenhaus
  • Neuss, Germany, 41462
    • TZN-Tumorzentrum Niederrhein GmbH
  • Nuremberg, Germany, 90403
    • Spital 2 medizinisches Institut PartG mbB
  • Nürtingen, Germany, 72622
    • Medius Klinik Nurtingen
  • Oldenburg, Germany, 26121
    • Pius Hospital Oldenburg
  • Oldenburg, Germany, 26121
    • ONSO GbR
  • Oranienburg, Germany, 16515
    • Oberhavel Kliniken GmbH
  • Osnabrück, Germany, 49076
    • Klinikum Osnabrueck GmbH
  • Paderborn, Germany, 33098
    • St. Vincenz-Krankenhaus GmbH
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergmann gGmbH
  • Ravensburg, Germany, 88212
    • MVZ für Hämatologie und Onkologie
  • Recklinghausen, Germany, 45659
    • Oncologianova GmbH
  • Remscheid, Germany, 42853
    • Group practice Remscheid
  • Remscheid, Germany, 42853
    • Private practice Remscheid
  • Remscheid, Germany, 42859
    • Onkologie Zentrum Süd MVZ GmbH
  • Rheine, Germany, 12489
    • Gemeinschaftspraxis für internistische Hämatologie und Onkologie
  • Rinteln, Germany, 31737
    • Nädler GmbH
  • Rostock, Germany, 18057
    • Private practice Markmann
  • Rostock, Germany, 18059
    • Klinikum Suedstadt Rostock, Universitaetsfrauenklinik
  • Rotenburg (Wümme), Germany, 27356
    • Agaplesion Diakonieklinik Rotenburg gGmbH
  • Rüsselsheim am Main, Germany, 65428
    • GPR Klinikum Rüsselsheim
  • Saarbrücken, Germany, 66113
    • CaritasKlinikum St. Theresia
  • Saarlouis, Germany, 66740
    • Krankenhaus Saarlouis vom DRK
  • Scheibenberg, Germany, 09481
    • Private practice Schubert
  • Schkeuditz, Germany, 04435
    • MedCenter Nordsachsen - Studien
  • Schorndorf, Germany, 73614
    • Onkster GbR
  • Schweinfurt, Germany, 97422
    • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
  • Schwerte, Germany, 58239
    • Marienkrankenhaus Schwerte
  • Schwäbisch Hall, Germany, 74523
    • Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH
  • Siegburg, Germany, 53721
    • Group Practice Esser
  • Singen (Hohentwiel), Germany, 78224
    • Group practice Singen
  • Soest, Germany, 59494
    • Onkologiezentrum Soest/Iserlohn
  • Solingen, Germany, 42653
    • Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde
  • Speyer, Germany, 67346
    • Group practice Behringer
  • Stade, Germany, 21680
    • MVZ Klinik Dr. Hancken GmbH
  • Stendal, Germany, 39576
    • Johanniter-Krankenhaus Genthin Stendal
  • Stendal, Germany, 39576
    • Private Practice Denck
  • Stohlberg, Germany, 52222
    • Clinical Research Stohlberg GmbH
  • Stralsund, Germany, 18439
    • Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
  • Stralsund, Germany, 18435
    • Private practice Stralsund
  • Stuttgart, Germany, 70199
    • Vinzenz von Paul Kliniken gGmbH Marienhospital
  • Stuttgart, Germany, 70174
    • Klinikum der Landeshauptstadt Stuttgart gKAoeR
  • Suhl, Germany, 98527
    • SRH Zentralklinikum Suhl GmbH
  • Suhl, Germany, 98527
    • Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl
  • Sömmerda, Germany, 99610
    • KMG Klinikum Sömmerda
  • Traunstein, Germany, 83278
    • Klinikum Traunstein
  • Traunstein, Germany, 83278
    • Group Practice Kronawitter
  • Troisdorf, Germany, 53840
    • Group practice Forstbauer
  • Twistringen, Germany, 27239
    • Private practice Weissenborn
  • Völklingen, Germany, 66333
    • Group practice Wagner
  • Weinheim, Germany, 69469
    • GRN Klinik Weinheim
  • Weißenfels, Germany, 06667
    • Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum
  • Wesel, Germany, 46483
    • MVZ Marien-Hospital Wesel GmbH
  • Westerstede, Germany, 26655
    • Medizinische Studiengesellschaft Nord-West GmbH
  • Wetzlar, Germany, 35578
    • Lahn-Dill-Kliniken GmbH
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden
  • Wilhelmshaven, Germany, 26389
    • Gruop practice Rodemer / Wismann / Distelrath
  • Winnenden, Germany, 71364
    • Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe
  • Witten, Germany, 58452
    • GIM - Gemeinschaftspraxis Innere Medizin
  • Wolfsburg, Germany, 38440
    • Group practice Wolfsburg
  • Wuppertal, Germany, 42283
    • Helios Universitätsklinikum Wuppertal GmbH
  • Würzburg, Germany, 97080
    • Group practice Wuerzburg
  • Würzburg, Germany, 97080
    • Universitätsklinikum Wuerzburg AoeR
  • Bavaria
    • Bayreuth, Bavaria, Germany, 95445
      • Klinikum Bayreuth GmbH
    • Nuremberg, Bavaria, Germany, 90419
      • Klinikum Nürnberg
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03048
      • Medizinische Universität Lausitz Carl Thiem
  • Lower Saxony
    • Goslar, Lower Saxony, Germany, 38642
      • Onkologische Kooperation Harz
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53113
      • Johanniter-MVZ Bonn GmbH
  • Other
    • Bad Mergentheim, Other, Germany, 97980
      • Caritas-Krankenhaus Bad Mergentheim
    • Berlin, Other, Germany, 12107
      • Mvz Etgo Gmbh
    • Bremen, Other, Germany, 28209
      • Onkologisch-Hämatologische Schwerpunktpraxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First-line Palbociclib + endocrine therapy; Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort-specific PFS of second-line treatment	Cohorts are defined by substance class of second-line therapy following first-line endocrine-based palbociclib therapy	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)
Objective response rate (ORR) of first- and second-line treatment		from date of start of first-/ 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
Duration of response (DoR) of first- and second-line treatment		from the date of first documented tumor response during first-/ second-line treatment until to the date of first subsequent documented disease progression or to death due to any cause, whichever came first, assessed up to 7.5 years
Disease control rate (DCR) of first- and second-line treatment		proportion of patients with documented tumor response during first-/second-line treatment (as assessed by local investigator in routine clinical practice) or stable disease (SD) over a period of at least 24 weeks after start of first-line treatment
Progression-free survival (PFS) of third-line treatment		from date of start of third-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
Time to first subsequent therapy (TFST)		from date of start of first-line treatment until the date of start of first subsequent systemic antineoplastic treatment, assessed up to 7.5 years
Time to first subsequent chemotherapy (TFSC)		from date of start of first-line treatment until the date of start of first subsequent systemic chemotherapy or chemotherapy-based antineoplastic treatment, assessed up to 7.5 years
Change from baseline in the FACT-B total score	The FACT-B is a 37-item instrument designed to measure five domains of Health-Relaed Quality of Life (HRQOL) in breast cancer patients: Physical Well-being (PWB), Social/family Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) as well as a Breast Cancer Subscale (BCS). Utilized with the 27 core FACT-G items, the FACT-B was developed with an emphasis on patients' values and brevity. For all questions, participants are asked to respond to a 5-point Likert-type scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The higher the score, the better the QOL (minimum 0; maximum 148).	from the date of first questionnaire assessment until the date of last questionnaire assessment, assessed at baseline, thereafter 3-monthly until end of study, and at the end of palbociclib treatment, up to 7.5 years.
Change from baseline in the FACT-G total score	The FACT-G is a 27-item instrument designed to measure four domains of HRQOL in breast cancer patients: PWB, SWB, EWB, and FWB. For all questions, participants are asked to respond to a 5-point Likert-type scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The higher the score, the better the QOL (minimum 0; maximum 108).	from the date of first questionnaire assessment until the date of last questionnaire assessment, assessed at baseline, thereafter 3-monthly until end of study, and at the end of palbociclib treatment, up to 7.5 years.
Change from baseline in the FACT-B subscales scores: PWB, SWB, EWB, FWB and additional concerns for BCS.	The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: PWB, SWB, EWB, FWB as well as a BCS. Utilized with the 27 core FACT-G items, the FACT-B was developed with an emphasis on patients' values and brevity. For all questions, participants are asked to respond to a 5-point Likert-type scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The higher the score, the better the QOL (PWB: minimum 0; maximum 28. SWB: minimum 0; maximum 28. EWB: minimum 0; maximum 24. FWB: minimum 0; maximum 28. BCS: minimum 0; maximum 40).	from the date of first questionnaire assessment until the date of last questionnaire assessment, assessed at baseline, thereafter 3-monthly until end of study, and at the end of palbociclib treatment, up to 7.5 years.
Change from baseline in FACT-B Trial Outcome Index (TOI)	The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: PWB, SWB, EWB, FWB as well as a BCS. Utilized with the 27 core FACT-G items, the FACT-B was developed with an emphasis on patients' values and brevity. The TOI combines the PWB+FWB+BCS items, making it 24-items altogether. For all questions, participants are asked to respond to a 5-point Likert-type scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The higher the score, the better the QOL (minimum 0; maximum 96).	from the date of first questionnaire assessment until the date of last questionnaire assessment, assessed at baseline, thereafter 3-monthly until end of study, and at the end of palbociclib treatment, up to 7.5 years.
Time to deterioration (TTD) in FACT-B total score	The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: PWB, SWB, EWB, FWB as well as a BCS. Utilized with the 27 core FACT-G items, the FACT-B was developed with an emphasis on patients' values and brevity. For all questions, participants are asked to respond to a 5-point Likert-type scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The higher the score, the better the QOL (minimum 0; maximum 148).	From the date of first questionnaire assessment until the date of first subsequent questionnaire with a decrease of ≥ 7 points in FACT-B total score or death, whichever came first, assessed up to 7.5 years.
Landmark analyses of cohort-specific Area Under the Curve (AUC) in the Functional Assessment of Cancer Therapy - Breast (FACT-B) TOI-Physical/Functional/Breast (TOI-PFB)	Cohorts are defined by substance class of second-line therapy following first-line endocrine-based palbociclib therapy.	From the date of first questionnaire assessment until 12, 24, 36, 48 months thereafter (irrespective of disease or treatment situation at that time point)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; palbociclib
• Other Study ID Numbers: A5481152; PERFORM-NIS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.