Palbociclib in Real World Practice

NCT03280303 | Completed Results

• 2 other identifiers: A5481082POLARIS
• Study Type: observational
• Target: 1,285
• Locations: 2 countries
• Sites: 305

Brief Summary

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Conditions

Advanced Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (61)

• Number of Participants According to Real-World Tumor Response

  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.

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

• Real-World Tumor Response Rate

  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.

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

• Real World Progression Free Survival

  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.

  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)

• Overall Survival

  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.

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

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

  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).

  Baseline (last observed measurement prior to treatment start date)

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

  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).

  Month 1

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

  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).

  Month 2

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

  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).

  Month 3

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

  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).

  Month 6

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

  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).

  Month 9

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

  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).

  Month 12

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

  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).

  Month 15

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

  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).

  Month 18

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

  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).

  Month 21

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

  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).

  Month 24

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

  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).

  Month 27

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

  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).

  Month 30

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

  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).

  Month 33

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

  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).

  Month 36

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

  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).

  Month 39

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

  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).

  Month 42

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

  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.

  Baseline (last observed measurement prior to treatment start date)

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

  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.

  Month 1

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

  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.

  Month 2

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

  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.

  Month 3

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

  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.

  Month 6

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

  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.

  Month 9

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

  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.

  Month 12

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

  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.

  Month 15

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

  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.

  Month 18

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

  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.

  Month 21

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

  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.

  Month 24

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

  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.

  Month 27

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

  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.

  Month 30

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

  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.

  Month 33

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

  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.

  Month 36

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

  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.

  Month 39

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

  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.

  Month 42

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

  Baseline (last observed measurement prior to treatment start date)

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

  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.

  Month 1

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

  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.

  Month 2

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

  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.

  Month 3

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

  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.

  Month 6

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

  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.

  Month 9

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

  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.

  Month 12

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

  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.

  Month 15

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

  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.

  Month 18

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

  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.

  Month 21

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

  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.

  Month 24

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

  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.

  Month 27

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

  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.

  Month 30

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

  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.

  Month 33

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

  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.

  Month 36

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

  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.

  Month 39

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

  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.

  Month 42

• Number of Participants With Adverse Events

  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.

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

• Number of Participants With Serious Adverse Events

  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.

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

• Number of Participants With Any Clinical Laboratory Abnormalities

  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.

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

Study Arms (1)

non-interventional study

This prospective, observational study will be conducted according to each site's routine clinical practice.

Other: non-interventional

Interventions

non-interventional OTHER

non-interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age ≥18 years or older.
• Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
• Documented HR+ (ER+ and/or PR+) tumor based on local standards.
• Documented HER2- tumor based on local standards.
• Physician has determined that treatment with palbociclib is indicated.
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
• Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.

You may not qualify if:

• Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
• Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
• Patients on active treatment for malignancies other than ABC at the time of enrollment.
• Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (305)

Alabama Oncology

Alabaster, Alabama, 35007, United States

Location

Alabama Oncology

Bessemer, Alabama, 35022, United States

Location

Alabama Oncology

Birmingham, Alabama, 35205, United States

Location

Alabama Oncology

Birmingham, Alabama, 35209, United States

Location

Alabama Oncology

Birmingham, Alabama, 35211, United States

Location

Alabama Oncology

Birmingham, Alabama, 35235, United States

Location

Grandview Cancer Center, Alabama Oncology

Birmingham, Alabama, 35243, United States

Location

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Central Arkansas Radiation Therapy Institute

Little Rock, Arkansas, 72205, United States

Location

Central Arkansas Radiation Therapy Institute

Stuttgart, Arkansas, 72160, United States

Location

Sutter Auburn

Auburn, California, 95602, United States

Location

AIS Cancer Center at Adventist Health Bakersfield

Bakersfield, California, 93301, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Providence Health and Services Southern California

Burbank, California, 91505, United States

Location

Enloe Regional Cancer Center

Chico, California, 95926, United States

Location

John Muir Clinical Research Center

Concord, California, 94520, United States

Location

John Muir Medical Center, Concord Campus

Concord, California, 94520, United States

Location

Mount Diablo Solano Oncology Group

Concord, California, 94520, United States

Location

Global Cancer Research Institute, Inc.

Gilroy, California, 95020, United States

Location

Breastlink Medical Group, Inc.

Laguna Hills, California, 92653, United States

Location

Breastlink Medical Group, Inc.

Newport Beach, California, 92660, United States

Location

Breastlink Medical Group, Inc.

Orange, California, 92868, United States

Location

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Petaluma, California, 94954, United States

Location

Diablo Valley Oncology Hematology Medical Group

Pleasant Hill, California, 94523, United States

Location

Epic Care

Pleasant Hill, California, 94523, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Salinas Valley Medical Clinic Cancer Care

Salinas, California, 93901, United States

Location

Salinas Valley Memorial Healthcare System

Salinas, California, 93901, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Cancer Research Collaboration/Breastlink Medical Group, Inc.

Santa Ana, California, 92705, United States

Location

Ridley Tree Cancer Center

Santa Barbara, California, 93105, United States

Location

SANSUM Clinic

Santa Barbara, California, 93105, United States

Location

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

Sansum Clinic

Solvang, California, 93463, United States

Location

St. Helena Hospital

St. Helena, California, 94574, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Stockton Hematology Oncology Medical Group

Stockton, California, 95204, United States

Location

Cancer Treatment Center of Vacaville

Vacaville, California, 95687, United States

Location

Solano Hematology Oncology

Vallejo, California, 94589, United States

Location

Contra Costa Oncology

Walnut Creek, California, 94598, United States

Location

John Muir Medical Center, Walnut Creek Camous

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Colorado West Healthcare System, dba Community Hospital

Grand Junction, Colorado, 81505, United States

Location

Colorado West Healthcare System, dba Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

Location

Rocky Mountain Cancer Centers

Lakewood, Colorado, 80228, United States

Location

Rocky Mountain Cancer Centers

Littleton, Colorado, 80120, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers

Parker, Colorado, 80138, United States

Location

Rocky Mountain Cancer Centers

Pueblo, Colorado, 81008, United States

Location

Rocky Mountain Cancer Centers

Thornton, Colorado, 80260, United States

Location

Western Connecticut Health Network

Danbury, Connecticut, 06810, United States

Location

Western Connecticut Health Network

New Milford, Connecticut, 06776, United States

Location

Western Connecticut Health Network

Norwalk, Connecticut, 06856, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20037, United States

Location

Florida Cancer Research Institute

Boca Raton, Florida, 33428, United States

Location

Boca Raton Regional Hospital/Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Cancer Specialists of North Florida

Fleming Island, Florida, 32003, United States

Location

Southeast Florida Hematology-Oncology Group, PA

Fort Lauderdale, Florida, 33308, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32204, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32207, United States

Location

University of Florida Health

Jacksonville, Florida, 32209, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32250, United States

Location

Cancer Specialists LLC

Jacksonville, Florida, 32256, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32258, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

Baptist Health Medical Group Oncology, LLC

Miami, Florida, 33176, United States

Location

Baptist Health Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

Location

Cancer Specialists of North Florida - St. Vincent's Clay

Middleburg, Florida, 32086, United States

Location

Millennium Oncology Research Clinic/Hematology and Oncology Private Practice

Pembroke, Florida, 33024, United States

Location

Baptist Health Miami Cancer Institute

Plantation, Florida, 33313, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Cancer Specialists of North Florida

Saint Augustine, Florida, 32086, United States

Location

Baptist Health Urgent Care Sawgrass

Sunrise, Florida, 33323, United States

Location

Northwest Georgia Oncology Centers, PC

Austell, Georgia, 30106, United States

Location

Northwest Georgia Oncology Centers, PC

Carrollton, Georgia, 30117, United States

Location

Northwest Georgia Oncology Centers, PC

Cartersville, Georgia, 30121, United States

Location

Northwest Georgia Oncology Centers, PC

Douglasville, Georgia, 30134, United States

Location

Gwinnett Hospital System, Inc. The Center for Cancer Care

Duluth, Georgia, 30096, United States

Location

Gwinnett Hospital System, Inc.

Duluth, Georgia, 30096, United States

Location

Gwinnett Hospital System Inc.

Lawrenceville, Georgia, 30046, United States

Location

Gwinnett Hospital System, Inc. The Center for Cancer Care

Lawrenceville, Georgia, 30046, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

Northwest Georgia Oncology Centers, PC

Roswell, Georgia, 30076, United States

Location

Candler Medical Oncology Practice (CMOP)/Summit Cancer Care

Savannah, Georgia, 31404, United States

Location

Summit Cancer Care Research

Savannah, Georgia, 31404, United States

Location

Candler Medical Oncology Practice (CMOP)

Savannah, Georgia, 31405, United States

Location

Gwinnett Hospital System, Inc. The Center for Cancer Care

Snellville, Georgia, 30078, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

Location

Presence St. Mary's Cancer Center

Bourbonnais, Illinois, 60914, United States

Location

Presence Saint Joseph Hospital

Chicago, Illinois, 60657, United States

Location

North Shore Oncology Hematology Associates

Crystal Lake, Illinois, 60014, United States

Location

North Shore Oncology-Hematology Associates

Crystal Lake, Illinois, 60014, United States

Location

Presence Infusion Care - Evanston

Evanston, Illinois, 60202, United States

Location

Joliet Oncology-Hematology Associates, LTD

Joliet, Illinois, 60435, United States

Location

Advocate Condell Medical Center

Libertyville, Illinois, 60048, United States

Location

North Shore Oncology-Hematology Associates

Libertyville, Illinois, 60048, United States

Location

Joliet Oncology-Hematology Associates, LTD

Morris, Illinois, 60450, United States

Location

Joliet Oncology-Hematology Associates, LTD

New Lenox, Illinois, 60451, United States

Location

Mid Illinois Hematology And Oncology Associates, Limited

Normal, Illinois, 61761, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

Location

Presence Infusion Care - Skokie

Skokie, Illinois, 60077, United States

Location

Oncology Hematology Associates of Southwest Indiana

Newburgh, Indiana, 47630, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010-3014, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Stormont Vail Regional Health Center

Topeka, Kansas, 66604, United States

Location

Stormont Vail Cotton O'Neill Cancer Center

Topeka, Kansas, 66606, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Our Lady of the Lake Physician Group, Louisiana Hematology Oncology Associates

Baton Rouge, Louisiana, 70809, United States

Location

Our Lady of the Lake Regional Medical Center, Oncology 6

Baton Rouge, Louisiana, 70809, United States

Location

Pontchartrain Cancer Center

Covington, Louisiana, 70433, United States

Location

Pontchartrain Cancer Center

Hammond, Louisiana, 70403, United States

Location

Cancer Center at West Jefferson Medical Center, New Orleans Physician Services, Inc.

Marrero, Louisiana, 70072, United States

Location

Crescent City Research Consortium, LLC

Marrero, Louisiana, 70072, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Maryland Oncology and Hematology, PA

Bethesda, Maryland, 20817, United States

Location

The Office of Frederick P. Smith, MD

Chevy Chase, Maryland, 20815, United States

Location

Maryland Oncology Hematology, P.A.

Clinton, Maryland, 20735, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Maryland Oncology Hematology, P.A.

Frederick, Maryland, 21702, United States

Location

Antietam Oncology and Hematology Group, PC

Haggerstown, Maryland, 21740, United States

Location

Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

Location

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20902, United States

Location

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20904, United States

Location

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Great Lakes Cancer Management

Grosse Pointe Woods, Michigan, 48236, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Great Lakes Cancer Management

Warren, Michigan, 48093, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Minnesota Oncology Hematology, PA

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Fairview Southdale Medical Oncology Clinic

Edina, Minnesota, 55435, United States

Location

University of Minnesota Health Maple Grove Clinics

Maple Grove, Minnesota, 55369, United States

Location

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, 55404, United States

Location

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Health Partners Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Minnesota Oncology Hematology, PA

Saint Paul, Minnesota, 55102, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology Hematology, PA

Woodbury, Minnesota, 55125, United States

Location

North Mississippi Medical Center, Inc., Hematology and Oncology Research

Tupelo, Mississippi, 38801, United States

Location

Mercy Clinic St. Louis Cancer and Breast Institute

Ballwin, Missouri, 63011, United States

Location

St. Louis Cancer Care, LLP

Bridgeton, Missouri, 63044, United States

Location

St. Louis Cancer Care, LLP

Chesterfield, Missouri, 63017, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. Luke's Cancer Institute - East

Kansas City, Missouri, 64086, United States

Location

St. Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

St. Luke's Cancer Institute - Liberty

Liberty, Missouri, 64068, United States

Location

University of Kansas Cancer Center

North Kansas City, Missouri, 64116, United States

Location

Heartland Regional Medical Center/dba Cancer Care St. Joseph Mosaic Life Care

Saint Joseph, Missouri, 64507, United States

Location

Mercy Clinic St. Louis Cancer and Breast Institute

St Louis, Missouri, 63109, United States

Location

SSM Health St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

St. Louis Cancer Care, LLP

St Louis, Missouri, 63128, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Mercy Research - Mercy Heart Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Nebraska Hematology/Oncology, PC

Lincoln, Nebraska, 68506, United States

Location

Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States

Location

Hackensack University Medical Center, John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

St. Luke's University Heatlh Network - Warren Hospital

Phillipsburg, New Jersey, 08865, United States

Location

CareMount Medical

Brewster, New York, 10509, United States

Location

New York Cancer and Blood Specialists

East Setauket, New York, 11733, United States

Location

CareMount Medical

Mount Kisco, New York, 10549, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

New York Cancer and Blood Specialists

Patchogue, New York, 11772, United States

Location

New York Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

New York Cancer and Blood Specialists

Riverhead, New York, 11901, United States

Location

New York Cancer and Blood Specialists

Smithtown, New York, 11787, United States

Location

White Plains Hospital

White Plains, New York, 10601, United States

Location

Asheville Hematology and Oncology

Asheville, North Carolina, 28803, United States

Location

Johnston Health Services Corporation - Clayton

Clayton, North Carolina, 27520, United States

Location

Haywood Infusion Center

Clyde, North Carolina, 28721, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28304, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28311, United States

Location

East Carolina University Brody School of Medicine

Greenville, North Carolina, 27834, United States

Location

DLP Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Advent Health - Hendersonville

Hendersonville, North Carolina, 28792, United States

Location

University of North Carolina Regional Physicians Hematology Oncology

High Point, North Carolina, 27262, United States

Location

Novant Health Oncology Specialists

Kernersville, North Carolina, 27284, United States

Location

Duke Cancer Network

Laurinburg, North Carolina, 28352, United States

Location

Southeastern Regional Medical Center

Lumberton, North Carolina, 27358, United States

Location

Novant Health Oncology Specialists

Mount Airy, North Carolina, 27030, United States

Location

Novant Health Oncology Specialists

North Wilkesboro, North Carolina, 28659, United States

Location

Johnston Health Services Corporation - Smithfield

Smithfield, North Carolina, 27577, United States

Location

Novant Health Oncology Specialists

Statesville, North Carolina, 28687, United States

Location

Novant Health Oncology Specialists

Thomasville, North Carolina, 27360, United States

Location

Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Hematology Oncology Associates, Inc.

Canton, Ohio, 44708, United States

Location

Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center

Columbus, Ohio, 43219, United States

Location

Tri-County Hematology and Oncology Associates, Inc.

Dover, Ohio, 44622, United States

Location

Tri-County Hematology and Oncology Associates, Inc.

Massillon, Ohio, 44646, United States

Location

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, 43551, United States

Location

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Mercy Health Cancer Center

Toledo, Ohio, 46323, United States

Location

Mercy Health Youngstown dba St Joseph Warren Hospital

Warren, Ohio, 44484, United States

Location

Mercy Health Youngstown dba St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Northwest Cancer Specialists, PC

Portland, Oregon, 97213, United States

Location

Northwest Cancer Specialists, PC

Portland, Oregon, 97225, United States

Location

Willamette Valley Cancer Institute and Research Center

Springfield, Oregon, 97477, United States

Location

St. Luke's University Health Network - Sacred Heart Hospital

Allentown, Pennsylvania, 18102, United States

Location

St. Luke's Hospital - Allentown Campus

Allentown, Pennsylvania, 18104, United States

Location

St. Luke's Hematology Oncology Specialists

Bethlehem, Pennsylvania, 18015, United States

Location

St. Luke's University Heatlh Network

Bethlehem, Pennsylvania, 18015, United States

Location

St. Luke's Hematology Oncology Specialists

Bethlehem, Pennsylvania, 18104, United States

Location

St. Luke's University Heatlh Network

Easton, Pennsylvania, 18045, United States

Location

Pinnacle Health Cancer Center

Harrisburg, Pennsylvania, 17109, United States

Location

Pinnacle Health Cancer Institute

Harrisburg, Pennsylvania, 17109, United States

Location

Lancaster Cancer Center

Lancaster, Pennsylvania, 17605, United States

Location

Ortenzio Cancer Center at Pinnacle Health

Mechanicsburg, Pennsylvania, 17050, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Greenville Health System

Easley, South Carolina, 29640, United States

Location

Tidelands Waccamaw Oncology/Georgrtown Hospital System

Georgetown, South Carolina, 29440, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

Greenville Health System

Greer, South Carolina, 29650, United States

Location

Carolina Blood and Cancer Care Associates, PA

Lancaster, South Carolina, 29720, United States

Location

Tidelands Waccamaw Oncology/Georgrtown Hospital System

Murrells Inlet, South Carolina, 29576, United States

Location

Tidelands Waccamaw Oncology/Georgrtown Hospital System

Myrtle Beach, South Carolina, 29577, United States

Location

Carolina Blood and Cancer Care Associates, PA

Rock Hill, South Carolina, 29732, United States

Location

Greenville Health System

Seneca, South Carolina, 29672, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Greenville Health System

Spartanburg, South Carolina, 29307, United States

Location

M. Francisco Gonzalez, MD, PA

Sumter, South Carolina, 29150, United States

Location

Wellmont Bristol Regional Medical Center

Bristol, Tennessee, 37620, United States

Location

Wellmont Medical Associates Oncology and Hematology

Bristol, Tennessee, 37620, United States

Location

University of Tennessee/Erlanger Oncology and Hematology

Chattanooga, Tennessee, 37403, United States

Location

Wellmont Medical Associates Oncology and Hematology

Johnson City, Tennessee, 37601, United States

Location

Wellmont Cancer Institute

Kingsport, Tennessee, 37660, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Texas Oncology -Allen

Allen, Texas, 75013, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

Texas Oncology-Denton South

Denton, Texas, 76210, United States

Location

Texas Oncology-El Paso Cancer Treatment Center

El Paso, Texas, 79902, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

Texas Oncology - Southwest Fort Worth

Fort Worth, Texas, 76132, United States

Location

Texas Oncology

Houston, Texas, 77024, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University Medical Center Health System, Southwest Cancer Center

Lubbock, Texas, 79415, United States

Location

Texas Oncology

McAllen, Texas, 78503, United States

Location

Texas Oncology - McKinney

McKinney, Texas, 75071, United States

Location

Texas Oncology

Mesquite, Texas, 75150, United States

Location

Texas Oncology-Paris

Paris, Texas, 75460, United States

Location

Texas Oncology

Plano, Texas, 75075, United States

Location

Texas Oncology-San Antonio Downtown

San Antonio, Texas, 78212, United States

Location

Texas Oncology

San Antonio, Texas, 78217, United States

Location

Texas Oncology-San Antonio Stone Oak

San Antonio, Texas, 78258, United States

Location

Texas Oncology

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists

Arlington, Virginia, 22205, United States

Location

Wellmont Medical Associates Oncology and Hematology

Bristol, Virginia, 24201, United States

Location

Cancer Specialists of Tidewater/Riverside Cancer Infusion Center

Chesapeake, Virginia, 23320, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Augusta Health Cancer Center

Fishersville, Virginia, 22939, United States

Location

Virginia Cancer Specialists

Gainesville, Virginia, 20155, United States

Location

Peninsula Cancer Institute/Riverside Cancer Infusion Center

Gloucester, Virginia, 23061, United States

Location

Virginia Cancer Specialists

Leesburg, Virginia, 20176, United States

Location

Bon Secours Memorial Regional Medical Center, Inc.

Mechanicsville, Virginia, 23116, United States

Location

Bon Secours Richmond Community Hospital dba Oncology Associates at Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

Location

Bon Secours Cancer Institute @ St. Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

Bon Secours Richmond Community Hospital dba Oncology Associates at St. Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

Bon Secours St. Francis Medical Center, Inc.

Midlothian, Virginia, 23114, United States

Location

Riverside Shore Cancer Center

Nassawadox, Virginia, 23413, United States

Location

Peninsula Cancer Institute/Riverside Cancer Infusion Center

Newport News, Virginia, 23601, United States

Location

Southwest Virginia Regional Cancer Center

Norton, Virginia, 24273, United States

Location

Delta Hematology/Oncology Associates

Portsmouth, Virginia, 23704, United States

Location

Bon Secours Richmond Community Hospital dba Oncologists Associates at St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Bon Secours St. Mary's Hospital, Inc.

Richmond, Virginia, 23226, United States

Location

Cancer Specialists of Tidewater/Riverside Cancer Infusion Center

Suffolk, Virginia, 23435, United States

Location

Cancer Specialists of Tidewater/Riverside Cancer Infusion Center

Virginia Beach, Virginia, 23454, United States

Location

Peninsula Cancer Institute/Riverside Cancer Infusion Center

Williamsburg, Virginia, 23185, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Northwest Cancer Specialists, PC

Vancouver, Washington, 98684, United States

Location

West Virginia University Medicine - United Hospital Center

Bridgeport, West Virginia, 26330, United States

Location

Huntington Internal Medicine Group

Huntington, West Virginia, 25705, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25705, United States

Location

West Virginia University, Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Camden Clark Medical Center

Parkersburg, West Virginia, 26101, United States

Location

Burnaby Hospital Cancer Centre

Burnaby, British Columbia, V5G 2X6, Canada

Location

Trillium Health Partners

Mississauga, Ontario, L5M 2N1, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Integrated University Center for Health and Social Services (CIUSSS) of Saguenay-Lac Saint Jean

Chicoutimi, Quebec, G74 5H6, Canada

Location

Related Publications (9)

• Tripathy 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.

  PMID: 41140056 DERIVED

• Rocque 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.

  PMID: 40971858 DERIVED

• Tripathy 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.

  PMID: 40825169 DERIVED

• Rocque 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.

  PMID: 40553419 DERIVED

• Rocque 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.

  PMID: 39581892 DERIVED

• Tripathy 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.

  PMID: 39475418 DERIVED

• Karuturi 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.

  PMID: 38061288 DERIVED

• Blum 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.

  PMID: 37903899 DERIVED

• Tripathy 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.

  PMID: 32787449 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 12, 2017
• Study Start: January 4, 2017
• Primary Completion: October 1, 2022
• Study Completion: December 22, 2022
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (301); CA (4)