Palbociclib in Real World Practice

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

POLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY

ClinicalTrials.gov ID

NCT03280303

Acronym / sponsor ID

A5481082

Conditions

Advanced Breast Cancer, Metastatic Breast Cancer

Study type

Observational

Recruitment status

Completed

Enrolment

1,285 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

4 Jan 2017 (actual)

Primary completion

1 Oct 2022 (actual)

Study completion

22 Dec 2022 (actual)

First posted

12 Sep 2017 (actual)

Results

Posted 20 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants According to Real-World Tumor Response

   Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)

   Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.

2. Real-World Tumor Response Rate

   Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)

   Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.

3. Real World Progression Free Survival

   Time frame: From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)

   Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.

4. Overall Survival

   Time frame: From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)

   Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.

5. Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only

   Time frame: Baseline (last observed measurement prior to treatment start date)

   ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

6. ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only

   Time frame: Month 1

   ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

7. ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only

   Time frame: Month 2

   ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

8. ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only

   Time frame: Month 3

   ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

9. ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only

   Time frame: Month 6

   ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

10. ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only

    Time frame: Month 9

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

11. ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only

    Time frame: Month 12

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

12. ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only

    Time frame: Month 15

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

13. ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only

    Time frame: Month 18

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

14. ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only

    Time frame: Month 21

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

15. ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only

    Time frame: Month 24

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

16. ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only

    Time frame: Month 27

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

17. ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only

    Time frame: Month 30

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

18. ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only

    Time frame: Month 33

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

19. ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only

    Time frame: Month 36

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

20. ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only

    Time frame: Month 39

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

21. ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only

    Time frame: Month 42

    ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

22. Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only

    Time frame: Baseline (last observed measurement prior to treatment start date)

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

23. Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only

    Time frame: Month 1

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

24. Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only

    Time frame: Month 2

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

25. Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only

    Time frame: Month 3

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

26. Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only

    Time frame: Month 6

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

27. Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only

    Time frame: Month 9

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

28. Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only

    Time frame: Month 12

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

29. Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only

    Time frame: Month 15

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

30. Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only

    Time frame: Month 18

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

31. Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only

    Time frame: Month 21

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

32. Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only

    Time frame: Month 24

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

33. Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only

    Time frame: Month 27

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

34. Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only

    Time frame: Month 30

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

35. Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only

    Time frame: Month 33

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

36. Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only

    Time frame: Month 36

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

37. Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only

    Time frame: Month 39

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

38. Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only

    Time frame: Month 42

    The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

39. Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline

    Time frame: Baseline (last observed measurement prior to treatment start date) and Month 6

    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

40. Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline

    Time frame: Baseline (last observed measurement prior to treatment start date) and Month 12

    EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

41. Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline

    Time frame: Baseline (last observed measurement prior to treatment start date) and Month 18

    EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

42. Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only

    Time frame: Baseline (last observed measurement prior to treatment start date)

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.

43. Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only

    Time frame: Month 1

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

44. Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only

    Time frame: Month 2

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

45. Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only

    Time frame: Month 3

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

46. Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only

    Time frame: Month 6

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

47. Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only

    Time frame: Month 9

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

48. Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only

    Time frame: Month 12

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

49. Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only

    Time frame: Month 15

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

50. Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only

    Time frame: Month 18

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.

51. Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only

    Time frame: Month 21

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

52. Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only

    Time frame: Month 24

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

53. Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only

    Time frame: Month 27

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

54. Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only

    Time frame: Month 30

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

55. Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only

    Time frame: Month 33

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

56. Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only

    Time frame: Month 36

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

57. Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only

    Time frame: Month 39

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

58. Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only

    Time frame: Month 42

    Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

59. Number of Participants With Adverse Events

    Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)

    An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.

60. Number of Participants With Serious Adverse Events

    Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).

    A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.

61. Number of Participants With Any Clinical Laboratory Abnormalities

    Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).

    Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 42017805Tripathy D, Blum JL, Karuturi MS, McCune S, Kurian S, Moezi MM, Anderson DM, Ji Y, Pluard TJ, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Impact of Comorbidities on Clinical Outcomes and Quality of Life of Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer Treated With Palbociclib in the POLARIS Study. Cancer Med. 2026 Apr;15(4):e71788. doi: 10.1002/cam4.71788.
• Derived from this study: PubMed 41140056Tripathy D, Blum JL, McCune S, Pluard T, Anderson D, Johnston A, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Real-world effectiveness of palbociclib plus hormone treatment and its impact on patient quality of life: a plain language summary of findings from POLARIS. Future Oncol. 2025 Nov;21(26):3359-3376. doi: 10.1080/14796694.2025.2570468. Epub 2025 Oct 27.
• Derived from this study: PubMed 40971858Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Gauthier E, Wang Y, Montelongo MZ, Cappelleri JC, Chen C, Karuturi MS, Tripathy D. Enhancing the interpretation of real-world quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer enrolled in the POLARIS study. Oncologist. 2025 Oct 1;30(10):oyaf281. doi: 10.1093/oncolo/oyaf281.
• Derived from this study: PubMed 40825169Tripathy D, Blum JL, Zhang H, Deng S, McCune SL, Patel K, Wang Y, Lakhanpal S, Karuturi MS, Zhang Z, Deshpande C, Montelongo MZ, Gauthier E, Liu Y, Rocque GB, Bardia A. Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving Palbociclib: Biomarker Results From POLARIS Study. JCO Precis Oncol. 2025 Aug;9:e2400810. doi: 10.1200/PO-24-00810. Epub 2025 Aug 18.
• Derived from this study: PubMed 40553419Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Gauthier E, Tripathy D. Relationship of Prior Anticancer Treatments with Palbociclib Clinical Outcomes in Patients with HR+/HER2- Advanced Breast Cancer in Real-World Settings. Target Oncol. 2025 Jul;20(4):679-692. doi: 10.1007/s11523-025-01158-0. Epub 2025 Jun 24.
• Derived from this study: PubMed 39581892Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Gauthier E, Wang Y, Montelongo MZ, Cappelleri JC, Karuturi MS, Tripathy D. Real-world quality-of-life of patients with HR+/HER2- advanced breast cancer treated with palbociclib plus endocrine therapy: EORTC QLQ-C30 results from POLARIS. Breast Cancer Res Treat. 2025 Feb;209(3):613-627. doi: 10.1007/s10549-024-07524-2. Epub 2024 Nov 25.
• Derived from this study: PubMed 39475418Tripathy D, Blum JL, Karuturi MS, McCune S, Kurian S, Moezi M, Anderson D, Gauthier E, Zhang Z, Montelongo MZ, Wang Y, Rocque GB. Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer: final results from the POLARIS trial. Oncologist. 2025 Jul 4;30(7):oyae291. doi: 10.1093/oncolo/oyae291.
• Derived from this study: PubMed 38061288Karuturi MS, Cappelleri JC, Blum JL, Patel K, Telivala B, McCune S, Cuevas JD, Lakhanpal S, Montelongo MZ, Wang Y, Tripathy D, Rocque GB. Measures of functional status in older patients treated with palbociclib for advanced breast cancer. J Geriatr Oncol. 2024 Jan;15(1):101670. doi: 10.1016/j.jgo.2023.101670. Epub 2023 Dec 6.
• Derived from this study: PubMed 37903899Blum JL, DiCristo C, Gordon D, Karuturi MS, Oubre D, Jepsen E, Cuevas J, Lakhanpal S, Montelongo MZ, Zhang Z, Cappelleri JC, Wang Y, Tripathy D. Outcomes of male patients with HR+/HER2- advanced breast cancer receiving palbociclib in the real-world POLARIS study. Breast Cancer Res Treat. 2024 Feb;203(3):463-475. doi: 10.1007/s10549-023-07145-1. Epub 2023 Oct 30.
• Derived from this study: PubMed 32787449Tripathy D, Blum JL, Rocque GB, Bardia A, Karuturi MS, Cappelleri JC, Liu Y, Zhang Z, Davis KL, Wang Y. POLARIS: a prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer. Future Oncol. 2020 Nov;16(31):2475-2485. doi: 10.2217/fon-2020-0573. Epub 2020 Aug 13.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

305 sites in 2 countries: see every site and its status.