Clinical trial NCT04767594: First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 1443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 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:
measure: Cohort-specific PFS of second-line treatment
timeFrame: 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
measure: Cohort-specific PFS2
timeFrame: 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
measure: Landmark progression-free survival rates (PFSR) of first- and second-line treatment
timeFrame: 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)
measure: Overall survival (OS)
timeFrame: from date of start of first-line treatment until the date of documented death from any cause, assessed up to 7.5 years
measure: Landmark overall survival rates (OSR)
timeFrame: 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)
measure: Objective response rate (ORR) of first- and second-line treatment
timeFrame: 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
measure: Duration of response (DoR) of first- and second-line treatment
timeFrame: 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
measure: Disease control rate (DCR) of first- and second-line treatment
timeFrame: 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
measure: Progression-free survival (PFS) of third-line treatment
timeFrame: 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
measure: Time to first subsequent therapy (TFST)
timeFrame: 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
measure: Time to first subsequent chemotherapy (TFSC)
timeFrame: 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
measure: Change from baseline in the FACT-B total score
timeFrame: 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.
measure: Change from baseline in the FACT-G total score
timeFrame: 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.
measure: Change from baseline in the FACT-B subscales scores: PWB, SWB, EWB, FWB and additional concerns for BCS.
timeFrame: 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.
measure: Change from baseline in FACT-B Trial Outcome Index (TOI)
timeFrame: 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.
measure: Time to deterioration (TTD) in FACT-B total score
timeFrame: 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.
measure: 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)
timeFrame: From the date of first questionnaire assessment until 12, 24, 36, 48 months thereafter (irrespective of disease or treatment situation at that time point)
Other outcomes:
Locations:
city: Braunau
country: Austria
facility: Sankt Josef Hospital Braunau
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Klagenfurt Am Woerthersee
country: Austria
facility: Klinikum Klagenfurt am Woerthersee
city: Salzburg
country: Austria
facility: Country Hospital Salzburg
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum Sankt Poelten
city: Schwaz
country: Austria
facility: Priv. Doz. OA Dr. Michael Hubalek
city: Vienna
country: Austria
facility: Oesterreichische Gesundheitskasse Hanusch-Krankenhaus
city: Wien
country: Austria
facility: Medizinische Universität Wien, Abteilung Innere Medizin I
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Nuernberg
country: Germany
facility: Klinikum Nürnberg
state: Bavaria
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
state: Bayern
city: Goslar
country: Germany
facility: Onkologische Kooperation Harz
state: Niedersachsen
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus Bad Mergentheim
state: Other
city: Berlin
country: Germany
facility: Mvz Etgo Gmbh
state: Other
city: Bremen
country: Germany
facility: Onkologisch-Hämatologische Schwerpunktpraxis
state: Other
city: Ansbach
country: Germany
facility: ANregiomed gKU
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
city: Augsburg
country: Germany
facility: Group practice Heinrich
city: Augsburg
country: Germany
facility: Group Practice Steinfeld-Birg
city: Bad Reichenhall
country: Germany
facility: Group practice Tanzer
city: Bad Soden a.T.
country: Germany
facility: Group practice Seipelt
city: Baden-Baden
country: Germany
facility: Klinikum Mittelbaden Baden-Baden Balg
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg Klinikum am Bruderwald
city: Bayreuth
country: Germany
facility: Private Practice Bayreuth
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Berlin
country: Germany
facility: Hämatologie Onkologie Berlin-Mitte
city: Berlin
country: Germany
facility: MediOnko-Institut GbR
city: Berlin
country: Germany
facility: DRK Kliniken Berlin-Köpenick Brustzentrum
city: Berlin
country: Germany
facility: Vivantes MVZ Hellersdorf - Zweigpraxis Biesdorf
city: Berlin
country: Germany
facility: Group practice Morack
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Frauenarzt-Zentrum-Zehlendorf
city: Biberach an der Riss
country: Germany
facility: Dr. Leonid Basovski Hämatologikum Biberach
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie
city: Bochum
country: Germany
facility: Group practice Bueckner
city: Boeblingen
country: Germany
facility: Kliniken Boeblingen
city: Bonn
country: Germany
facility: Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR
city: Bottrop
country: Germany
facility: Group practice Hannig
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
city: Bottrop
country: Germany
facility: ONKO DOK GbR
city: Brandenburg a.d.H.
country: Germany
facility: Private practice Brandenburg a.d.H.
city: Brandenburg an der Havel
country: Germany
facility: Staedtisches Klinikum Brandenburg GmbH
city: Bremerhaven
country: Germany
facility: Klinikum Bremerhaven Reinkenheide gGmbH
city: Bruchsal
country: Germany
facility: Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe
city: Celle
country: Germany
facility: AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Chemnitz
country: Germany
facility: Private Practice Jungberg
city: Datteln
country: Germany
facility: St. Vincenz-Krankenhaus
city: Donauwoerth
country: Germany
facility: Onkologiezentrum Donauwoerth
city: Dortmund
country: Germany
facility: Klinikum Dortmund Frauenklinik
city: Dortmund
country: Germany
facility: Studiengesellschaft Gefos Dortmund mbH
city: Dresden
country: Germany
facility: Group practice Goehler
city: Dresden
country: Germany
facility: Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Group practice Jacobasch
city: Dueren
country: Germany
facility: St. Marien-Hospital
city: Duisburg
country: Germany
facility: MVZ Duisburg Süd GmbH
city: Duisburg
country: Germany
facility: Naedler GmbH
city: Ebersberg
country: Germany
facility: Private Practice Groell
city: Eggenfelden
country: Germany
facility: Studienzentrale für das MVZ Eggenfelde e.K.
city: Eisenach
country: Germany
facility: St. Georg Klinikum Eisenach gGmbH
city: Erfurt
country: Germany
facility: Group practice Weniger
city: Erlangen
country: Germany
facility: Group practice Haecker
city: Fockbek
country: Germany
facility: imland gGmbH
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt Frauenheilkunde
city: Frechen
country: Germany
facility: pioh Studien und Management GbR
city: Freiburg
country: Germany
facility: Group Practice Dr. med. M. Zaiss
city: Freudenstadt
country: Germany
facility: KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe
city: Fuerth
country: Germany
facility: Group practice Fuerth
city: Georgsmarienhuette
country: Germany
facility: MVZ II der Niels Stensen Kliniken
city: Gera
country: Germany
facility: Onkostudien Gera GbR
city: Grafenau
country: Germany
facility: Private practice Rabenbauer
city: Guetersloh
country: Germany
facility: Onkodok GmbH
city: Gummersbach
country: Germany
facility: Klinikum Oberberg KKH Gummersbach
city: Haldensleben
country: Germany
facility: Group practice Neumeister
city: Halle (Saale)
country: Germany
facility: Group practice Behlendorf
city: Hamburg
country: Germany
facility: Studiengesellschaft Haemato-Onkologie Hamburg GbR
city: Hamburg
country: Germany
facility: Praxisklinik Harburger Ring
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus gGmbH Frauenklinik
city: Hamburg
country: Germany
facility: Überörtliche Gemeinschaftspraxis
city: Hameln
country: Germany
facility: Private Practice Rubanov
city: Hanau
country: Germany
facility: Klinikum Hanau Gynäkologisches Krebszentrum
city: Hannover
country: Germany
facility: Group Practice Kamal
city: Heidelberg
country: Germany
facility: Private Practice Fuxius
city: Heidenheim a.d.B.
country: Germany
facility: Private practice Petersen
city: Heide
country: Germany
facility: Westkuestenkliniken Heide und Brunsbuettel
city: Herford
country: Germany
facility: Mathilden-Hospital
city: Herrsching
country: Germany
facility: cancer Center Zweiseenland GbR
city: Hildburghausen
country: Germany
facility: Private Practice Dr. med. Andreas Lorenz
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dr.med. Ch. Uleer
city: Hof
country: Germany
facility: Onkologie Hof MVZ GmbH
city: Homberg
country: Germany
facility: Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,
city: Ilsede
country: Germany
facility: Frauenarzt Toralf Baerens
city: Itzehoe
country: Germany
facility: Klinikum Itzehoe
city: Kaiserslautern
country: Germany
facility: IDGGQ GbR
city: Karlsruhe
country: Germany
facility: ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG
city: Karlsruhe
country: Germany
facility: Diakonissenkrankenhaus Karlsruhe
city: Kaufbeuren
country: Germany
facility: Klinikum Kaufbeuren
city: Koblenz
country: Germany
facility: Institut fuer Versorgungsforschung in der Onkologie GbR
city: Koeln
country: Germany
facility: private practice Ziegler-Loehr
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus GmbH
city: Krefeld
country: Germany
facility: group practice Krefeld
city: Kronach
country: Germany
facility: Private practice Kronach
city: Kulmbach
country: Germany
facility: Klinikum Kulmbach
city: Königs Wusterhausen
country: Germany
facility: Klinikum Dahme-Spreewald GmbH
city: Landshut
country: Germany
facility: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut
city: Langen
country: Germany
facility: Group practice Koehler
city: Lebach
country: Germany
facility: Onkologisches Zentrum Lebach
city: Leer
country: Germany
facility: Group practice Mueller
city: Loerrach
country: Germany
facility: Group practice Knoblich
city: Lohsa
country: Germany
facility: Private practice Wierick
city: Luebeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein
city: Lüneburg
country: Germany
facility: Onkologie Zentrum Lüneburg Praxisgemeinschaft
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg Frauenheilkunde und Geburtshilfe
city: Mannheim
country: Germany
facility: Group practice Prof. Dr. M. Hensel
city: Marktredwitz
country: Germany
facility: Klinikum Fichtelgebirge gGmbH
city: Mayen
country: Germany
facility: Hämatologisch Onkologisches Studieninstitut
city: Mayen
country: Germany
facility: Institut für Versorgungsforschung GbR
city: Moenchengladbach
country: Germany
facility: Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH
city: Moers
country: Germany
facility: OnkoLog Moers GbR
city: Muehlheim
country: Germany
facility: Onko - Log Muelheim GbR
city: Muenchen
country: Germany
facility: Klinikum Dritter Orden
city: Muenchen
country: Germany
facility: Group practice Schmidt
city: Muhlhausen
country: Germany
facility: MVZ GmbH-Muehlhausen
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend
city: Naunhof
country: Germany
facility: Private practice Naunhof
city: Neubrandenburg
country: Germany
facility: Frauenärztin Neubrandenburg Dr. m Ines Vanselow-Geßner
city: Neuenahr-Ahrweller
country: Germany
facility: Group Practice Nacke
city: Neumuenster
country: Germany
facility: Friedrich-Ebert-Krankenhaus
city: Neuss
country: Germany
facility: TZN-Tumorzentrum Niederrhein GmbH
city: Neustadt a.R.
country: Germany
facility: Group practice Tschechne
city: Nuernberg
country: Germany
facility: Spital 2 medizinisches Institut PartG mbB
city: Nuertingen
country: Germany
facility: medius Klinik Nürtingen
city: Oldenburg
country: Germany
facility: ONSO GbR
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
city: Oranienburg
country: Germany
facility: Oberhavel Kliniken GmbH
city: Osnabrueck
country: Germany
facility: Klinikum Osnabrueck GmbH
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Ravensburg
country: Germany
facility: Group practice Decker
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Remscheid
country: Germany
facility: Group practice Remscheid
city: Remscheid
country: Germany
facility: Private practice Remscheid
city: Remscheid
country: Germany
facility: Onkologie Zentrum Süd MVZ GmbH
city: Rheine
country: Germany
facility: Gemeinschaftspraxis für internistische Hämatologie und Onkologie
city: Rinteln
country: Germany
facility: Nadler GmbH
city: Rostock
country: Germany
facility: Private practice Markmann
city: Rostock
country: Germany
facility: Klinikum Suedstadt Rostock, Universitaetsfrauenklinik
city: Rotenburg (Wuemme)
country: Germany
facility: Agaplesion Diakonieklinik Rotenburg gGmbH
city: Ruesselsheim
country: Germany
facility: GPR Klinikum Rüsselsheim
city: Saarbrücken
country: Germany
facility: CaritasKlinikum St. Theresia
city: Saarlouis
country: Germany
facility: Krankenhaus Saarlouis vom DRK
city: Scheibenberg
country: Germany
facility: Private practice Schubert
city: Schkeuditz
country: Germany
facility: MedCenter Nordsachsen - Studien
city: Schorndorf
country: Germany
facility: Onkster GbR
city: Schwaebisch Hall
country: Germany
facility: Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
city: Schwerte
country: Germany
facility: Marienkrankenhaus Schwerte
city: Siegburg
country: Germany
facility: Group Practice Esser
city: Singen (Hohentwiel)
country: Germany
facility: Group practice Singen
city: Soemmerda
country: Germany
facility: KMG Klinikum Sömmerda
city: Soest
country: Germany
facility: Onkologiezentrum Soest/Iserlohn
city: Solingen
country: Germany
facility: Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde
city: Speyer
country: Germany
facility: Group practice Behringer
city: Stade
country: Germany
facility: MVZ Klinik Dr. Hancken GmbH
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin Stendal
city: Stendal
country: Germany
facility: Private Practice Denck
city: Stohlberg
country: Germany
facility: Clinical Research Stohlberg GmbH
city: Stralsund
country: Germany
facility: Private practice Stralsund
city: Stralsund
country: Germany
facility: Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart gKAoeR
city: Stuttgart
country: Germany
facility: Vinzenz von Paul Kliniken gGmbH Marienhospital
city: Suhl
country: Germany
facility: Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
city: Traunstein
country: Germany
facility: Group Practice Kronawitter
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Troisdorf
country: Germany
facility: Group practice Forstbauer
city: Twistringen
country: Germany
facility: Private practice Weissenborn
city: Ulm
country: Germany
facility: Private practice Wolf
city: Voelklingen
country: Germany
facility: Group practice Wagner
city: Weinheim
country: Germany
facility: GRN Klinik Weinheim
city: Weissenfels
country: Germany
facility: Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum
city: Wesel
country: Germany
facility: MVZ Marien-Hospital Wesel GmbH
city: Westerstede
country: Germany
facility: Medizinische Studiengesellschaft NORD-WEST GmbH
city: Wetzlar
country: Germany
facility: Lahn-Dill-Kliniken GmbH
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
city: Wilhelmshaven
country: Germany
facility: Gruop practice Rodemer / Wismann / Distelrath
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe
city: Witten
country: Germany
facility: GIM - Gemeinschaftspraxis Innere Medizin
city: Wolfsburg
country: Germany
facility: Group practice Wolfsburg
city: Wuerzburg
country: Germany
facility: Group practice Wuerzburg
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Wuerzburg AoeR
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal GmbH
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: