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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
PERFORM

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

Rekrutierend

NCT-Nummer:
NCT04767594

Studienbeginn:
Oktober 2020

Letztes Update:
27.07.2021

Wirkstoff:
Palbociclib + endocrine therapy

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 107)

Klinikum Hochsauerland GmbH
59759 Arnsberg
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Group practice Heinrich
86150 Augsburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Tanzer
83435 Bad Reichenhall
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Seipelt
65812 Bad Soden a.T.
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Sozialstiftung Bamberg Klinikum am Bruderwald
96049 Bamberg
(Bayern)
GermanyRekrutierend» Google-Maps
Private Practice Bayreuth
95445 Bayreuth
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Schilling
10317 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
MediOnko-Institut GbR
10367 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Private practice Ruhmland
12683 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Morack
13156 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Vivantes Netzwerk für Gesundheit GmbH
13407 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Bueckner
44787 Bochum
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Kliniken Boeblingen
71032 Boeblingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Group practice Hannig
46236 Bottrop
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Marienhospital Bottrop gGmbH
46236 Bottrop
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
ONKO DOK GbR
46236 Bottrop
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Brandenburg a.d.H.
14770 Brandenburg a.d.H.
(Brandenburg)
GermanyRekrutierend» Google-Maps
Group practice Schieder
21244 Buchholz
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Chemnitz gGmbH
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Private Practice Jungberg
09117 Chemnitz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Gynäkologisches Krebszentrum des DONAUISAR Klinikums Deggendorf
Perlasberger Straße 41
94469 Deggendorf
DeutschlandNoch nicht rekrutierend» Google-Maps
Onkologiezentrum Donauwoerth
86609 Donauwoerth
(Bayern)
GermanyRekrutierend» Google-Maps
Klinikum Dortmund Frauenklinik
44137 Dortmund
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Jacobasch
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Brustzentrum am St. Marien-Hospital Bonn
Robert-Koch-Straße 1
53115 Bonn
DeutschlandRekrutierend» Google-Maps
Private Practice Groell
85560 Ebersberg
(Bayern)
GermanyRekrutierend» Google-Maps
Group practice Weniger
99085 Erfurt
(Thüringen)
GermanyRekrutierend» Google-Maps
Group practice Haecker
91052 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
imland gGmbH
24787 Fockbek
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
private practice Freital
01705 Freital
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Krankenhaeuser Landkreis Freudenstadt
72250 Freudenstadt
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Group practice Fuerth
90766 Fuerth
(Bayern)
GermanyRekrutierend» Google-Maps
Onkostudien Gera GbR
07548 Gera
(Thüringen)
GermanyRekrutierend» Google-Maps
Private practice Rabenbauer
94481 Grafenau
(Bayern)
GermanyRekrutierend» Google-Maps
Private Practice Antje Kristina Belau
17489 Greifswald
(Mecklenburg-Vorpommern)
GermanyNoch nicht rekrutierend» Google-Maps
Onkodok GmbH
33332 Guetersloh
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Oberberg KKH Gummersbach
51643 Gummersbach
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Neumeister
39340 Haldensleben
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Group practice Behlendorf
06110 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Praxisklinik Harburger Ring
21073 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Private Practice Fuxius
69115 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Private practice Petersen
89522 Heidenheim a.d.B.
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Westkuestenkliniken Heide und Brunsbuettel
25746 Heide
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Mathilden-Hospital
32052 Herford
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
cancer Center Zweiseenland GbR
82211 Herrsching
(Bayern)
GermanyRekrutierend» Google-Maps
Universitätsklinik des Saarlandes Ausführende Stelle: Universitätsklinikum Homburg,
66421 Homberg
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Itzehoe
25524 Itzehoe
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Diakonissenkrankenhaus Karlsruhe
76199 Karlsruhe
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Institut fuer Versorgungsforschung in der Onkologie GbR
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
private practice Ziegler-Loehr
50679 Koeln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
St. Elisabeth Krankenhaus GmbH
50935 Koeln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Koeln
51103 Koeln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
group practice Krefeld
47805 Krefeld
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Kronach
96317 Kronach
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Kulmbach
95326 Kulmbach
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Onkologisches Zentrum Lebach
66822 Lebach
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Mueller
26789 Leer
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Knoblich
79539 Loerrach
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Private practice Wierick
02999 Lohsa
(Sachsen)
GermanyRekrutierend» Google-Maps
Klinikum Fichtelgebirge gGmbH
95615 Marktredwitz
(Bayern)
GermanyRekrutierend» Google-Maps
Institut für Versorgungsforschung GbR
56727 Mayen
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
OnkoLog Moers GbR
47441 Moers
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Brustzentrum Klinikum Dritter Orden München-Nymphenburg
Menzinger Straße 44
80638 München
DeutschlandNoch nicht rekrutierend» Google-Maps
MVZ GmbH-Muehlhausen
99974 Muhlhausen
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Stauferklinikum Schwaebisch Gmuend
73557 Mutlangen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Naunhof
04683 Naunhof
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Friedrich-Ebert-Krankenhaus
24534 Neumuenster
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Augustinus Kliniken, JEK
41462 Neuss
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
TZN-Tumorzentrum Niederrhein GmbH
41462 Neuss
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Tschechne
31535 Neustadt a.R.
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Hutzschenreuter
48527 Nordhorn
(Niedersachsen)
GermanyRekrutierend» Google-Maps
group practice Olbermann
46045 Oberhausen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Oberhavel Kliniken GmbH
16515 Oranienburg
(Brandenburg)
GermanyRekrutierend» Google-Maps
Paracelsus-Klinik Osnabrueck
49076 Osnabrueck
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
MVZ für Blut - und Krebserkrankungen Drs. Sauer / Gerhardt / Linde
14467 Potsdam
(Brandenburg)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Decker
88212 Ravensburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Oncologianova GmbH
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Remscheid
42853 Remscheid
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Remscheid
42853 Remscheid
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Kohnke
42859 Remscheid
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Markmann
18057 Rostock
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Agaplesion Diakonieklinik Rotenburg gGmbH
27356 Rotenburg (Wuemme)
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Krankenhaus Saarlouis vom DRK
66740 Saarlouis
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Schubert
09481 Scheibenberg
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
MedCenter Nordsachsen - Studien
04435 Schkeuditz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Onkster GbR
73614 Schorndorf
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Diakoneo Diakonie-Klinikum Schwaebisch Hall gGmbH
74523 Schwaebisch Hall
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
97422 Schweinfurt
(Bayern)
GermanyRekrutierend» Google-Maps
Marienkrankenhaus Schwerte
58239 Schwerte
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Singen
78224 Singen (Hohentwiel)
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Onkologiezentrum Soest/Iserlohn
59494 Soest
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Behringer
67346 Speyer
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
MVZ Klinik Dr. Hancken GmbH
21680 Stade
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Private practice Stralsund
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Frauenaerztliches Zentrum Suhl im medico Facharztzentrum MVZ GmbH Betriebsstaette Suhl
98527 Suhl
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
SRH Zentralklinikum Suhl GmbH
98527 Suhl
(Thüringen)
GermanyRekrutierend» Google-Maps
Darmzentrum Chiemgau am Klinikum Traunstein
Cuno-Niggl-Straße 3
83278 Traunstein
DeutschlandNoch nicht rekrutierend» Google-Maps
Group practice Forstbauer
53840 Troisdorf
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Private practice Weissenborn
27239 Twistringen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Private practice Wolf
89073 Ulm
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Group practice Wagner
66333 Voelklingen
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Weissenfels Frauenheilkunde, Geburtshilfe Brustzentrum
06667 Weissenfels
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Lahn-Dill-Kliniken GmbH
35578 Wetzlar
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Rems-Murr-Klinikum Winnenden Gynaekologie und Geburtshilfe
71364 Winnenden
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Group practice Wolfsburg
38440 Wolfsburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Group practice Wuerzburg
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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)



Secondary outcome:

1. Cohort-specific PFS of second-line treatment (Time Frame - 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):
Cohorts are defined by substance class of second-line therapy following first-line endocrine-based palbociclib therapy

2. Cohort-specific PFS2 (Time Frame - 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 (Time Frame - 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) (Time Frame - 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) (Time Frame - 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 (Time Frame - 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 (Time Frame - 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 (Time Frame - 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 (Time Frame - 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) (Time Frame - 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) (Time Frame - 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 (Time Frame - 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.):
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).

13. Change from baseline in the FACT-G total score (Time Frame - 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.):
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).

14. Change from baseline in the FACT-B subscales scores: PWB, SWB, EWB, FWB and additional concerns for BCS. (Time Frame - 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.):
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).

15. Change from baseline in FACT-B Trial Outcome Index (TOI) (Time Frame - 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.):
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).

16. Time to deterioration (TTD) in FACT-B total score (Time Frame - 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.):
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).

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) (Time Frame - From the date of first questionnaire assessment until 12, 24, 36, 48 months thereafter (irrespective of disease or treatment situation at that time point)):
Cohorts are defined by substance class of second-line therapy following first-line endocrine-based palbociclib therapy.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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