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

Breast Neoplasms Clinical Trial

— PERFORM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04767594
• Other study ID #: A5481152
• Secondary ID: PERFORM-NIS
• Status: Recruiting
• Start date: October 27, 2020
• Est. completion date: April 3, 2028

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1900
• Est. completion date: April 3, 2028
• Est. primary completion date: April 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Sankt Josef Hospital Braunau	Braunau
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt am Woerthersee	Klagenfurt Am Woerthersee
Austria	Country Hospital Salzburg	Salzburg
Austria	Universitaetsklinikum Sankt Poelten	Sankt Poelten
Austria	Priv. Doz. OA Dr. Michael Hubalek	Schwaz
Austria	Oesterreichische Gesundheitskasse Hanusch-Krankenhaus	Vienna
Austria	Medizinische Universität Wien	Wien
Austria	Medizinische Universität Wien, Abteilung Innere Medizin I	Wien
Germany	ANregiomed gKU	Ansbach
Germany	Klinikum Hochsauerland GmbH	Arnsberg
Germany	Group practice Heinrich	Augsburg
Germany	Group Practice Steinfeld-Birg	Augsburg
Germany	Caritas-Krankenhaus Bad Mergentheim	Bad Mergentheim	Other
Germany	Group practice Tanzer	Bad Reichenhall
Germany	Group practice Seipelt	Bad Soden a.T.
Germany	Klinikum Mittelbaden Baden-Baden Balg	Baden-Baden
Germany	Sozialstiftung Bamberg Klinikum am Bruderwald	Bamberg
Germany	Klinikum Bayreuth GmbH	Bayreuth	Bayern
Germany	Private Practice Bayreuth	Bayreuth
Germany	Charité - Universitaetsmedizin Berlin, Charité Campus Mitte	Berlin
Germany	DRK Kliniken Berlin-Köpenick Brustzentrum	Berlin
Germany	Frauenarzt-Zentrum-Zehlendorf	Berlin
Germany	Group practice Morack	Berlin
Germany	Hämatologie Onkologie Berlin-Mitte	Berlin
Germany	MediOnko-Institut GbR	Berlin
Germany	Mvz Etgo Gmbh	Berlin	Other
Germany	Private practice Ruhmland	Berlin
Germany	Private practice Schilling	Berlin
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Dr. Leonid Basovski Hämatologikum Biberach	Biberach an der Riss
Germany	Evangelisches Klinikum Bethel gGmbH, Klinik für Innere Medizin, Hämatologie, Onkologie	Bielefeld
Germany	Group practice Bueckner	Bochum
Germany	Group practice Bueckner	Bochum
Germany	Kliniken Boeblingen	Boeblingen
Germany	Praxiskooperation Onkologie Bonn / Euskirchen / Rheinbach / Wesseling GbR	Bonn
Germany	Group practice Hannig	Bottrop
Germany	Marienhospital Bottrop gGmbH	Bottrop
Germany	ONKO DOK GbR	Bottrop
Germany	Private practice Brandenburg a.d.H.	Brandenburg a.d.H.
Germany	Staedtisches Klinikum Brandenburg GmbH	Brandenburg an der Havel
Germany	Onkologisch-Hämatologische Schwerpunktpraxis	Bremen	Other
Germany	Klinikum Bremerhaven Reinkenheide gGmbH	Bremerhaven
Germany	Fürst-Stirum-Klinik Bruchsal Klinik für Frauenheilkunde und Geburtshilfe	Bruchsal
Germany	Group practice Schieder	Buchholz
Germany	AKH-Gruppe-Allgemeines Krankenhaus Celle + MVZ gGmbH	Celle
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Private Practice Jungberg	Chemnitz
Germany	St. Vincenz-Krankenhaus	Datteln
Germany	DONAUISAR Klinikum	Deggendorf
Germany	Onkologiezentrum Donauwoerth	Donauwoerth
Germany	Klinikum Dortmund Frauenklinik	Dortmund
Germany	Studiengesellschaft Gefos Dortmund mbH	Dortmund
Germany	Gemeinschaftspraxis	Dresden
Germany	Group practice Goehler	Dresden
Germany	Group practice Jacobasch	Dresden
Germany	St. Marien-Hospital	Dueren
Germany	MVZ Duisburg Süd GmbH	Duisburg
Germany	Naedler GmbH	Duisburg
Germany	Private Practice Groell	Ebersberg
Germany	Studienzentrale für das MVZ Eggenfelde e.K.	Eggenfelden
Germany	St. Georg Klinikum Eisenach gGmbH	Eisenach
Germany	Group practice Weniger	Erfurt
Germany	Group practice Haecker	Erlangen
Germany	imland gGmbH	Fockbek
Germany	Universitaetsklinikum Frankfurt Frauenheilkunde	Frankfurt am Main
Germany	pioh Studien und Management GbR	Frechen
Germany	Group Practice Dr. med. M. Zaiss	Freiburg
Germany	private practice Freital	Freital
Germany	KKH Landkreis Freudenstadt Frauenheilkunde und Geburtshilfe	Freudenstadt
Germany	Krankenhaeuser Landkreis Freudenstadt	Freudenstadt
Germany	Group practice Fuerth	Fuerth
Germany	MVZ II der Niels Stensen Kliniken	Georgsmarienhuette
Germany	Onkostudien Gera GbR	Gera
Germany	Private practice Rabenbauer	Grafenau
Germany	Private Practice Antje Kristina Belau	Greifswald
Germany	Onkodok GmbH	Guetersloh
Germany	Klinikum Oberberg KKH Gummersbach	Gummersbach
Germany	Group practice Neumeister	Haldensleben
Germany	Group practice Behlendorf	Halle (Saale)
Germany	Katholisches Marienkrankenhaus gGmbH Frauenklinik	Hamburg
Germany	Praxisklinik Harburger Ring	Hamburg
Germany	Studiengesellschaft Haemato-Onkologie Hamburg GbR	Hamburg
Germany	Überörtliche Gemeinschaftspraxis	Hamburg
Germany	Private Practice Rubanov	Hameln
Germany	Klinikum Hanau Gynäkologisches Krebszentrum	Hanau
Germany	Group Practice Kamal	Hannover
Germany	Westkuestenkliniken Heide und Brunsbuettel	Heide
Germany	Private Practice Fuxius	Heidelberg
Germany	Private practice Petersen	Heidenheim a.d.B.
Germany	Gemeinschaftskrankenhaus Herdecke gGmbH	Herdecke
Germany	Mathilden-Hospital	Herford
Germany	cancer Center Zweiseenland GbR	Herrsching
Germany	Private Practice Dr. med. Andreas Lorenz	Hildburghausen
Germany	Gemeinschaftspraxis Dr.med. Ch. Uleer	Hildesheim
Germany	Onkologie Hof MVZ GmbH	Hof
Germany	Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,	Homberg
Germany	Frauenarzt Toralf Baerens	Ilsede
Germany	Klinikum Itzehoe	Itzehoe
Germany	IDGGQ GbR	Kaiserslautern
Germany	Diakonissenkrankenhaus Karlsruhe	Karlsruhe
Germany	ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG	Karlsruhe
Germany	Klinikum Kaufbeuren	Kaufbeuren
Germany	Institut fuer Versorgungsforschung in der Onkologie GbR	Koblenz
Germany	Group practice Koeln	Koeln
Germany	private practice Ziegler-Loehr	Koeln
Germany	St. Elisabeth Krankenhaus GmbH	Koeln
Germany	Klinikum Dahme-Spreewald GmbH	Königs Wusterhausen
Germany	group practice Krefeld	Krefeld
Germany	Private practice Kronach	Kronach
Germany	Klinikum Kulmbach	Kulmbach
Germany	ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut	Landshut
Germany	Group practice Koehler	Langen
Germany	Onkologisches Zentrum Lebach	Lebach
Germany	Group practice Mueller	Leer
Germany	Group practice Knoblich	Loerrach
Germany	Private practice Wierick	Lohsa
Germany	Universitätsklinikum Schleswig Holstein	Luebeck
Germany	Onkologie Zentrum Lüneburg Praxisgemeinschaft	Lüneburg
Germany	Klinikum Magdeburg Frauenheilkunde und Geburtshilfe	Magdeburg
Germany	Universitätsklinikum Magdeburg Frauenklinik, Brustzentrum	Magdeburg
Germany	Group practice Prof. Dr. M. Hensel	Mannheim
Germany	Klinikum Fichtelgebirge gGmbH	Marktredwitz
Germany	Institut für Versorgungsforschung GbR	Mayen
Germany	Brustzentrum-Rhein-Ruhr Servicegesellschaft mbH	Moenchengladbach
Germany	OnkoLog Moers GbR	Moers
Germany	Onko - Log Muelheim GbR	Muehlheim
Germany	Group practice Schmidt	Muenchen
Germany	Klinikum Dritter Orden	Muenchen
Germany	MVZ GmbH-Muehlhausen	Muhlhausen
Germany	Stauferklinikum Schwaebisch Gmuend	Mutlangen
Germany	Private practice Naunhof	Naunhof
Germany	Frauenärztin Neubrandenburg - Dr. m Ines Vanselow-Geßner	Neubrandenburg
Germany	Group Practice Nacke	Neuenahr-Ahrweller
Germany	Friedrich-Ebert-Krankenhaus	Neumuenster
Germany	Augustinus Kliniken, JEK	Neuss
Germany	TZN-Tumorzentrum Niederrhein GmbH	Neuss
Germany	Group practice Tschechne	Neustadt a.R.
Germany	Group practice Hutzschenreuter	Nordhorn
Germany	Klinikum Nürnberg	Nuernberg	Bavaria
Germany	Spital 2 medizinisches Institut PartG mbB	Nuernberg
Germany	medius Klinik Nürtingen	Nuertingen
Germany	group practice Olbermann	Oberhausen
Germany	ONSO GbR	Oldenburg
Germany	Pius Hospital Oldenburg	Oldenburg
Germany	Oberhavel Kliniken GmbH	Oranienburg
Germany	Klinikum Osnabrueck GmbH	Osnabrueck
Germany	Paracelsus-Klinik Osnabrueck	Osnabrueck
Germany	St. Vincenz-Krankenhaus GmbH	Paderborn
Germany	Klinikum Ernst von Bergmann gGmbH	Potsdam
Germany	MVZ für Blut - und Krebserkrankungen Drs. Sauer / Gerhardt / Linde	Potsdam
Germany	Group practice Decker	Ravensburg
Germany	Oncologianova GmbH	Recklinghausen
Germany	Group practice Remscheid	Remscheid
Germany	Private practice Kohnke	Remscheid
Germany	Private practice Remscheid	Remscheid
Germany	Gemeinschaftspraxis für internistische Hämatologie und Onkologie	Rheine
Germany	Klinikum Suedstadt Rostock, Universitaetsfrauenklinik	Rostock
Germany	Private practice Markmann	Rostock
Germany	Agaplesion Diakonieklinik Rotenburg gGmbH	Rotenburg (Wuemme)
Germany	GPR Klinikum Rüsselsheim	Ruesselsheim
Germany	CaritasKlinikum St. Theresia	Saarbrücken
Germany	Krankenhaus Saarlouis vom DRK	Saarlouis
Germany	Private practice Schubert	Scheibenberg
Germany	MedCenter Nordsachsen - Studien	Schkeuditz
Germany	Onkster GbR	Schorndorf
Germany	Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH	Schwaebisch Hall
Germany	Leopoldina Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt
Germany	Marienkrankenhaus Schwerte	Schwerte
Germany	Group Practice Esser	Siegburg
Germany	Group practice Singen	Singen (Hohentwiel)
Germany	KMG Klinikum Sömmerda	Soemmerda
Germany	Onkologiezentrum Soest/Iserlohn	Soest
Germany	Staedtisches Klinikum Solingen gemeinützige GmbH, Klinik für Frauenheilkunde	Solingen
Germany	Group practice Behringer	Speyer
Germany	MVZ Klinik Dr. Hancken GmbH	Stade
Germany	Private Practice Denck	Stendal
Germany	Clinical Research Stohlberg GmbH	Stohlberg
Germany	Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher	Stralsund
Germany	Private practice Stralsund	Stralsund
Germany	Klinikum der Landeshauptstadt Stuttgart gKAoeR	Stuttgart
Germany	Vinzenz von Paul Kliniken gGmbH Marienhospital	Stuttgart
Germany	Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl	Suhl
Germany	SRH Zentralklinikum Suhl GmbH	Suhl
Germany	Group Practice Kronawitter	Traunstein
Germany	Klinikum Traunstein	Traunstein
Germany	Group practice Forstbauer	Troisdorf
Germany	Private practice Weissenborn	Twistringen
Germany	Private practice Wolf	Ulm
Germany	Group practice Wagner	Voelklingen
Germany	GRN Klinik Weinheim	Weinheim
Germany	Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum	Weissenfels
Germany	Medizinische Studiengesellschaft NORD-WEST GmbH	Westerstede
Germany	Lahn-Dill-Kliniken GmbH	Wetzlar
Germany	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden
Germany	Gruop practice Rodemer / Wismann / Distelrath	Wilhelmshaven
Germany	Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe	Winnenden
Germany	GIM - Gemeinschaftspraxis Innere Medizin	Witten
Germany	Group practice Wolfsburg	Wolfsburg
Germany	Group practice Wuerzburg	Wuerzburg
Germany	Universitätsklinikum Wuerzburg AoeR	Wuerzburg
Germany	Helios Universitätsklinikum Wuppertal GmbH	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)

External Links

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