AzTrials
AzTrials

Breast NeoplasmsPERFORMNCT04767594

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

An observational study of Breast Neoplasms, run by Pfizer at 192 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Palbociclib + endocrine therapy
How many people
1,407 participants
Where
192 sitesin 2 countries
Study dates
27 Oct 2020to 30 Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

192 sites in 2 countries.

192 sites in 2 countries

Germany183 sites

  • ANregiomed gKU

    Ansbach, 91522

  • Alexianer Klinikum Hochsauerland GmbH

    Arnsberg, 59759

  • Group practice Heinrich

    Augsburg, 86150

  • Group Practice Steinfeld-Birg

    Augsburg, 86150

  • Caritas-Krankenhaus Bad Mergentheim

    Bad Mergentheim, Other, 97980

  • Group practice Tanzer

    Bad Reichenhall, 83435

  • Group practice Seipelt

    Bad Soden a.T., 65812

  • Klinikum Mittelbaden Baden-Baden Balg

    Baden-Baden, 76532

  • Sozialstiftung Bamberg Klinikum am Bruderwald

    Bamberg, 96049

  • Klinikum Bayreuth GmbH

    Bayreuth, Bavaria, 95445

  • Private Practice Bayreuth

    Bayreuth, 95445

  • Mvz Etgo Gmbh

    Berlin, Other, 12107

  • Charité Campus Mitte

    Berlin, 10117

  • Hämatologie Onkologie Berlin-Mitte

    Berlin, 10117

  • MediOnko-Institut GbR

    Berlin, 10367

  • DRK Kliniken Berlin-Köpenick Brustzentrum

    Berlin, 12559

  • Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf

    Berlin, 12683

  • Group practice Morack

    Berlin, 13156

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 13407

  • Frauenarzt-Zentrum-Zehlendorf

    Berlin, 14169

  • Dr. Leonid Basovski Hämatologikum Biberach

    Biberach an der Riss, 85400

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

    Bielefeld, 33617

  • Kliniken Boeblingen

    Böblingen, 71032

  • Group practice Bueckner

    Bochum, 44787

  • Johanniter-MVZ Bonn GmbH

    Bonn, North Rhine-Westphalia, 53113

  • Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR

    Bonn, 53123

  • Group practice Hannig

    Bottrop, 46236

  • Marienhospital Bottrop gGmbH

    Bottrop, 46236

  • ONKO DOK GbR

    Bottrop, 46236

  • Private practice Brandenburg a.d.H.

    Brandenburg a.d.H., 14770

  • Staedtisches Klinikum Brandenburg GmbH

    Brandenburg an der Havel, 14770

  • Onkologisch-Hämatologische Schwerpunktpraxis

    Bremen, Other, 28209

  • Klinikum Bremerhaven Reinkenheide gGmbH

    Bremerhaven, 27574

  • Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe

    Bruchsal, 76646

  • AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH

    Celle, 29223

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Private Practice Jungberg

    Chemnitz, 09117

  • private practice Ziegler-Loehr

    Cologne, 50679

  • St. Elisabeth Krankenhaus GmbH

    Cologne, 50935

  • Medizinische Universität Lausitz Carl Thiem

    Cottbus, Brandenburg, 03048

  • St. Vincenz-Krankenhaus

    Datteln, 45711

  • Onkologiezentrum Donauwoerth

    Donauwörth, 86609

  • Klinikum Dortmund Frauenklinik

    Dortmund, 44137

  • Studiengesellschaft Gefos Dortmund mbH

    Dortmund, 44263

  • Group practice Goehler

    Dresden, 01127

  • Gemeinschaftspraxis

    Dresden, 01307

  • Group practice Jacobasch

    Dresden, 01307

  • Naedler GmbH

    Duisburg, 47166

  • St. Marien-Hospital

    Düren, 52353

  • Private Practice Groell

    Ebersberg, 85560

  • Studienzentrale für das MVZ Eggenfelde e.K.

    Eggenfelden, 84307

  • St. Georg Klinikum Eisenach gGmbH

    Eisenach, 99817

  • Group practice Weniger

    Erfurt, 99085

  • Group practice Haecker

    Erlangen, 91052

  • imland gGmbH

    Fockbek, 24787

  • Universitaetsklinikum Frankfurt Frauenheilkunde

    Frankfurt am Main, 60590

  • pioh Studien und Management GbR

    Frechen, 50226

  • Group Practice Dr. med. M. Zaiss

    Freiburg im Breisgau, 79110

  • KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe

    Freudenstadt, 72250

  • Group practice Fuerth

    Fürth, 90766

  • MVZ II der Niels Stensen Kliniken

    Georgsmarienhütte, 49124

  • Onkostudien Gera GbR

    Gera, 07548

  • Onkologische Kooperation Harz

    Goslar, Lower Saxony, 38642

  • Private practice Rabenbauer

    Grafenau, 94481

  • Klinikum Oberberg KKH Gummersbach

    Gummersbach, 51643

  • Onkodok GmbH

    Gütersloh, 33332

  • Group practice Neumeister

    Haldensleben I, 39340

  • Group practice Behlendorf

    Halle, 06110

  • Studiengesellschaft Haemato-Onkologie Hamburg GbR

    Hamburg, 20251

  • Praxisklinik Harburger Ring

    Hamburg, 21073

  • Katholisches Marienkrankenhaus gGmbH Frauenklinik

    Hamburg, 22087

  • Überörtliche Gemeinschaftspraxis

    Hamburg, 48415

  • Private Practice Rubanov

    Hamelin, 31785

  • Klinikum Hanau Gynäkologisches Krebszentrum

    Hanau, 63450

  • Group Practice Kamal

    Hanover, 30625

  • Westkuestenkliniken Heide und Brunsbuettel

    Heide, 25746

  • Private Practice Fuxius

    Heidelberg, 69115

  • Private practice Petersen

    Heidenheim a.d.B., 89522

  • Mathilden-Hospital

    Herford, 32052

  • cancer Center Zweiseenland GbR

    Herrsching am Ammersee, 82211

  • Private Practice Dr. med. Andreas Lorenz

    Hildburghausen, 98646

  • Gemeinschaftspraxis Dr.med. Ch. Uleer

    Hildesheim, 31134

  • Onkologie Hof MVZ GmbH

    Hof, 95028

  • Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,

    Homberg (Efze), 66421

  • Frauenarzt Toralf Baerens

    Ilsede, 31241

  • Klinikum Itzehoe

    Itzehoe, 25524

  • IDGGQ GbR

    Kaiserslautern, 67655

  • ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76135

  • Diakonissenkrankenhaus Karlsruhe

    Karlsruhe, 76199

  • Klinikum Kaufbeuren

    Kaufbeuren, 87600

  • Institut fuer Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

  • Klinikum Dahme-Spreewald GmbH

    Königs Wusterhausen, 15711

  • group practice Krefeld

    Krefeld, 47805

  • Private practice Kronach

    Kronach, 96317

  • Klinikum Kulmbach

    Kulmbach, 95326

  • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut

    Landshut, 84036

  • Group practice Koehler

    Langen, 63225

  • Onkologisches Zentrum Lebach

    Lebach, 66822

  • Group practice Mueller

    Leer, 26789

  • Group practice Knoblich

    Loerrach, 79539

  • Private practice Wierick

    Lohsa, 02999

  • Universitätsklinikum Schleswig Holstein

    Lübeck, 23538

  • Onkologie Zentrum Lüneburg Praxisgemeinschaft

    Lüneburg, 21335

  • Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum

    Magdeburg, 39108

  • Klinikum Magdeburg Frauenheilkunde und Geburtshilfe

    Magdeburg, 39130

  • Group practice Prof. Dr. M. Hensel

    Mannheim, 63739

  • Klinikum Fichtelgebirge gGmbH

    Marktredwitz, 95615

  • Hämatologisch Onkologisches Studieninstitut

    Mayen, 56727

  • MVZ Hämatologie/Onkologie

    Mayen, 56727

  • OnkoLog Moers GbR

    Moers, 47441

  • Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH

    Mönchengladbach, 41061

  • MVZ GmbH-Muehlhausen

    Mühlhausen, 99974

  • Onko - Log Muelheim GbR

    Mühlheim, 45468

  • Klinikum Dritter Orden

    München, 80638

  • Group practice Schmidt

    München, 81241

  • Stauferklinikum Schwaebisch Gmuend

    Mutlangen, 73557

  • Private practice Naunhof

    Naunhof, 04683

  • Dr Ines Vanselor Gessner U A Kagelmacher

    Neubrandenburg, 17036

  • Group Practice Nacke

    Neuenahr-Ahrweller, 53474

  • Friedrich-Ebert-Krankenhaus

    Neumünster, 24534

  • TZN-Tumorzentrum Niederrhein GmbH

    Neuss, 41462

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90419

  • Spital 2 medizinisches Institut PartG mbB

    Nuremberg, 90403

  • medius Klinik Nürtingen

    Nürtingen, 72622

  • ONSO GbR

    Oldenburg, 26121

  • Pius Hospital Oldenburg

    Oldenburg, 26121

  • Oberhavel Kliniken GmbH

    Oranienburg, 16515

  • Klinikum Osnabrueck GmbH

    Osnabrück, 49076

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • MVZ für Hämatologie und Onkologie

    Ravensburg, 88212

  • Oncologianova GmbH

    Recklinghausen, 45659

  • Group practice Remscheid

    Remscheid, 42853

  • Private practice Remscheid

    Remscheid, 42853

  • Onkologie Zentrum Süd MVZ GmbH

    Remscheid, 42859

  • Gemeinschaftspraxis für internistische Hämatologie und Onkologie

    Rheine, 12489

  • Nadler GmbH

    Rinteln, 31737

  • Private practice Markmann

    Rostock, 18057

  • Klinikum Suedstadt Rostock, Universitaetsfrauenklinik

    Rostock, 18059

  • Agaplesion Diakonieklinik Rotenburg gGmbH

    Rotenburg (Wümme), 27356

  • GPR Klinikum Rüsselsheim

    Rüsselsheim am Main, 65428

  • CaritasKlinikum St. Theresia

    Saarbrücken, 66113

  • Krankenhaus Saarlouis vom DRK

    Saarlouis, 66740

  • Private practice Schubert

    Scheibenberg, 09481

  • MedCenter Nordsachsen - Studien

    Schkeuditz, 04435

  • Onkster GbR

    Schorndorf, 73614

  • Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH

    Schwäbisch Hall, 74523

  • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

    Schweinfurt, 97422

  • Marienkrankenhaus Schwerte

    Schwerte, 58239

  • Group Practice Esser

    Siegburg, 53721

  • Group practice Singen

    Singen (Hohentwiel), 78224

  • Onkologiezentrum Soest/Iserlohn

    Soest, 59494

  • Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde

    Solingen, 42653

  • KMG Klinikum Sömmerda

    Sömmerda, 99610

  • Group practice Behringer

    Speyer, 67346

  • MVZ Klinik Dr. Hancken GmbH

    Stade, 21680

  • Johanniter-Krankenhaus Genthin Stendal

    Stendal, 39576

  • Private Practice Denck

    Stendal, 39576

  • Clinical Research Stohlberg GmbH

    Stohlberg, 52222

  • Private practice Stralsund

    Stralsund, 18435

  • Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher

    Stralsund, 18439

  • Klinikum der Landeshauptstadt Stuttgart gKAoeR

    Stuttgart, 70174

  • Vinzenz von Paul Kliniken gGmbH Marienhospital

    Stuttgart, 70199

  • Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl

    Suhl, 98527

  • SRH Zentralklinikum Suhl GmbH

    Suhl, 98527

  • Group Practice Kronawitter

    Traunstein, 83278

  • Klinikum Traunstein

    Traunstein, 83278

  • Group practice Forstbauer

    Troisdorf, 53840

  • Private practice Weissenborn

    Twistringen, 27239

  • Group practice Wagner

    Völklingen, 66333

  • GRN Klinik Weinheim

    Weinheim, 69469

  • Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum

    Weißenfels, 06667

  • MVZ Marien-Hospital Wesel GmbH

    Wesel, 46483

  • Medizinische Studiengesellschaft NORD-WEST GmbH

    Westerstede, 26655

  • Lahn-Dill-Kliniken GmbH

    Wetzlar, 35578

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

  • Gruop practice Rodemer / Wismann / Distelrath

    Wilhelmshaven, 26389

  • Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe

    Winnenden, 71364

  • GIM - Gemeinschaftspraxis Innere Medizin

    Witten, 58452

  • Group practice Wolfsburg

    Wolfsburg, 38440

  • Helios Universitätsklinikum Wuppertal GmbH

    Wuppertal, 42283

  • Group practice Wuerzburg

    Würzburg, 97080

  • Universitätsklinikum Wuerzburg AoeR

    Würzburg, 97080

Other trials in Germany

Austria9 sites

  • Sankt Josef Hospital Braunau

    Braunau am Inn, 5280

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt am Woerthersee

    Klagenfurt, 9020

  • Country Hospital Salzburg

    Salzburg, 5020

  • Universitaetsklinikum Sankt Poelten

    Sankt Pölten, 3100

  • Priv. Doz. OA Dr. Michael Hubalek

    Schwaz, 6130

  • Medizinische Universität Wien, Abteilung Innere Medizin I

    Vienna, 1090

  • Medizinische Universität Wien

    Vienna, 1090

  • Oesterreichische Gesundheitskasse Hanusch-Krankenhaus

    Vienna, 1140

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Being tested
Palbociclib + endocrine therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib + endocrine therapyDrug

    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.

Study groups in NCT04767594
Study groupRoleWhat they receive
First-line Palbociclib + endocrine therapyPalbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy
Receives: Drug: Palbociclib + endocrine therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: 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)

  1. Cohort-specific PFS of second-line treatment

    Cohorts are defined by substance class of second-line therapy following first-line endocrine-based palbociclib therapy

    Measured: 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

  2. Cohort-specific PFS2

    Measured: 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

  3. Landmark progression-free survival rates (PFSR) of first- and second-line treatment

    Measured: 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)

  4. Overall survival (OS)

    Measured: from date of start of first-line treatment until the date of documented death from any cause, assessed up to 7.5 years

  5. Landmark overall survival rates (OSR)

    Measured: 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)

  6. Objective response rate (ORR) of first- and second-line treatment

    Measured: 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

  7. Duration of response (DoR) of first- and second-line treatment

    Measured: 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

  8. Disease control rate (DCR) of first- and second-line treatment

    Measured: 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

  9. Progression-free survival (PFS) of third-line treatment

    Measured: 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

  10. Time to first subsequent therapy (TFST)

    Measured: 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

  11. Time to first subsequent chemotherapy (TFSC)

    Measured: 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

  12. 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).

    Measured: 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.

  13. 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).

    Measured: 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.

  14. 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).

    Measured: 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.

  15. 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).

    Measured: 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.

  16. 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).

    Measured: 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.

  17. 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.

    Measured: From the date of first questionnaire assessment until 12, 24, 36, 48 months thereafter (irrespective of disease or treatment situation at that time point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start27 Oct 2020
  3. Primary completion3 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767594
Sponsor's protocol ID
A5481152
Other IDs
PERFORM-NIS
Acronym
PERFORM
Status last verified
Apr 2026
First submitted
21 Jan 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

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.

    PubMed 36427183

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Pfizer at 192 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767594, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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