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.
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
Sie können folgenden Inhalt einem Kollegen empfehlen:
"First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting."
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