Palbociclib in Real World Practice
- Conditions
- Advanced Breast CancerMetastatic Breast Cancer
- Interventions
- Other: non-interventional
- Registration Number
- NCT03280303
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1285
Not provided
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Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
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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).
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Patients on active treatment for malignancies other than ABC at the time of enrollment.
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Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-interventional study non-interventional This prospective, observational study will be conducted according to each site's routine clinical practice.
- Primary Outcome Measures
Name Time Method Number of Participants According to Real-World Tumor Response 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.
Real-World Tumor Response Rate 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.
Real World Progression Free Survival 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.
Overall Survival 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.
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only 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).
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only 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).
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only 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.
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only 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.
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only 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.
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline 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.
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline 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.
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline 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.
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only 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.
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only 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.
Number of Participants With Adverse Events 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.
Number of Participants With Serious Adverse Events 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.
Number of Participants With Any Clinical Laboratory Abnormalities 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (209)
John Muir Clinical Research Center
🇺🇸Concord, California, United States
Baptist Health Miami Cancer Institute
🇺🇸Plantation, Florida, United States
Western Connecticut Health Network
🇺🇸Norwalk, Connecticut, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Solano Hematology Oncology
🇺🇸Vallejo, California, United States
Heartland Regional Medical Center/dba Cancer Care St. Joseph Mosaic Life Care
🇺🇸Saint Joseph, Missouri, United States
Mercy Clinic St. Louis Cancer and Breast Institute
🇺🇸Saint Louis, Missouri, United States
SSM Health St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
St. Luke's Cancer Institute - Liberty
🇺🇸Liberty, Missouri, United States
Providence Health and Services Southern California
🇺🇸Burbank, California, United States
Mount Diablo Solano Oncology Group
🇺🇸Concord, California, United States
Ridley Tree Cancer Center
🇺🇸Santa Barbara, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
AIS Cancer Center at Adventist Health Bakersfield
🇺🇸Bakersfield, California, United States
Epic Care
🇺🇸Pleasant Hill, California, United States
Breastlink Medical Group, Inc.
🇺🇸Orange, California, United States
Cancer Treatment Center of Vacaville
🇺🇸Vacaville, California, United States
Texas Oncology
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists
🇺🇸Leesburg, Virginia, United States
Texas Oncology-El Paso Cancer Treatment Center
🇺🇸El Paso, Texas, United States
Texas Oncology-Paris
🇺🇸Paris, Texas, United States
Augusta Health Cancer Center
🇺🇸Fishersville, Virginia, United States
John Muir Medical Center, Concord Campus
🇺🇸Concord, California, United States
Central Arkansas Radiation Therapy Institute
🇺🇸Stuttgart, Arkansas, United States
Enloe Regional Cancer Center
🇺🇸Chico, California, United States
Sutter Auburn
🇺🇸Auburn, California, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Baptist Health Medical Group Oncology, LLC
🇺🇸Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Texas Oncology-San Antonio Stone Oak
🇺🇸San Antonio, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology-San Antonio Downtown
🇺🇸San Antonio, Texas, United States
West Virginia University Medicine - United Hospital Center
🇺🇸Bridgeport, West Virginia, United States
Millennium Oncology Research Clinic/Hematology and Oncology Private Practice
🇺🇸Pembroke, Florida, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Oncology Hematology Associates of Southwest Indiana
🇺🇸Newburgh, Indiana, United States
Bon Secours Memorial Regional Medical Center, Inc.
🇺🇸Mechanicsville, Virginia, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Grandview Cancer Center, Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Novant Health Oncology Specialists
🇺🇸Winston-Salem, North Carolina, United States
Metro-Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Health Partners Institute
🇺🇸Saint Louis Park, Minnesota, United States
Great Lakes Cancer Management
🇺🇸Warren, Michigan, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Nebraska Hematology/Oncology, PC
🇺🇸Lincoln, Nebraska, United States
Rocky Mountain Cancer Centers
🇺🇸Thornton, Colorado, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Diablo Valley Oncology Hematology Medical Group
🇺🇸Pleasant Hill, California, United States
Global Cancer Research Institute, Inc.
🇺🇸Gilroy, California, United States
Cancer Research Collaboration/Breastlink Medical Group, Inc.
🇺🇸Santa Ana, California, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Santa Clara Valley Medical Center
🇺🇸San Jose, California, United States
St. Helena Hospital
🇺🇸Saint Helena, California, United States
Salinas Valley Medical Clinic Cancer Care
🇺🇸Salinas, California, United States
SANSUM Clinic
🇺🇸Santa Barbara, California, United States
Sansum Clinic
🇺🇸Solvang, California, United States
Southeast Florida Hematology-Oncology Group, PA
🇺🇸Fort Lauderdale, Florida, United States
Cancer Specialists LLC
🇺🇸Jacksonville, Florida, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Stockton Hematology Oncology Medical Group
🇺🇸Stockton, California, United States
Contra Costa Oncology
🇺🇸Walnut Creek, California, United States
John Muir Medical Center, Walnut Creek Camous
🇺🇸Walnut Creek, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Baptist Health Urgent Care Sawgrass
🇺🇸Sunrise, Florida, United States
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Boca Raton Regional Hospital/Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
University of Florida Health
🇺🇸Jacksonville, Florida, United States
Gwinnett Hospital System Inc.
🇺🇸Lawrenceville, Georgia, United States
Candler Medical Oncology Practice (CMOP)/Summit Cancer Care
🇺🇸Savannah, Georgia, United States
Cancer Specialists of North Florida
🇺🇸Saint Augustine, Florida, United States
Gwinnett Hospital System, Inc. The Center for Cancer Care
🇺🇸Snellville, Georgia, United States
Gwinnett Hospital System, Inc.
🇺🇸Duluth, Georgia, United States
Cancer Specialists of North Florida - St. Vincent's Clay
🇺🇸Middleburg, Florida, United States
Presence St. Mary's Cancer Center
🇺🇸Bourbonnais, Illinois, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Summit Cancer Care Research
🇺🇸Savannah, Georgia, United States
Candler Medical Oncology Practice (CMOP)
🇺🇸Savannah, Georgia, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Mid Illinois Hematology And Oncology Associates, Limited
🇺🇸Normal, Illinois, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Presence Infusion Care - Evanston
🇺🇸Evanston, Illinois, United States
Mercy Medical Center
🇺🇸Canton, Ohio, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Presence Saint Joseph Hospital
🇺🇸Chicago, Illinois, United States
Maryland Oncology and Hematology, PA
🇺🇸Bethesda, Maryland, United States
North Shore Oncology-Hematology Associates
🇺🇸Libertyville, Illinois, United States
Advocate Condell Medical Center
🇺🇸Libertyville, Illinois, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Stormont Vail Regional Health Center
🇺🇸Topeka, Kansas, United States
Stormont Vail Cotton O'Neill Cancer Center
🇺🇸Topeka, Kansas, United States
Joliet Oncology-Hematology Associates, LTD
🇺🇸New Lenox, Illinois, United States
Presence Infusion Care - Skokie
🇺🇸Skokie, Illinois, United States
North Shore Oncology Hematology Associates
🇺🇸Crystal Lake, Illinois, United States
Our Lady of the Lake Regional Medical Center, Oncology 6
🇺🇸Baton Rouge, Louisiana, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
University of Kansas Cancer Center
🇺🇸North Kansas City, Missouri, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Crescent City Research Consortium, LLC
🇺🇸Marrero, Louisiana, United States
New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Our Lady of the Lake Physician Group, Louisiana Hematology Oncology Associates
🇺🇸Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center
🇺🇸Hammond, Louisiana, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Minnesota Oncology Hematology, PA
🇺🇸Woodbury, Minnesota, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Park Nicollet Frauenshuh Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
The Office of Frederick P. Smith, MD
🇺🇸Chevy Chase, Maryland, United States
Maryland Oncology Hematology, P.A.
🇺🇸Silver Spring, Maryland, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
University of Minnesota Health Maple Grove Clinics
🇺🇸Maple Grove, Minnesota, United States
Antietam Oncology and Hematology Group, PC
🇺🇸Haggerstown, Maryland, United States
St. Luke's Cancer Institute
🇺🇸Kansas City, Missouri, United States
North Mississippi Medical Center, Inc., Hematology and Oncology Research
🇺🇸Tupelo, Mississippi, United States
Hackensack University Medical Center, John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
St. Louis Cancer Care, LLP
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
East Carolina University Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Hematology Oncology Associates, Inc.
🇺🇸Canton, Ohio, United States
Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Boone Hospital Center
🇺🇸Columbia, Missouri, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Johnston Health Services Corporation - Smithfield
🇺🇸Smithfield, North Carolina, United States
Mercy Research - Mercy Heart Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Southeastern Regional Medical Center
🇺🇸Lumberton, North Carolina, United States
Tri-County Hematology and Oncology Associates, Inc.
🇺🇸Massilon, Ohio, United States
New York Cancer and Blood Specialists
🇺🇸Smithtown, New York, United States
Asheville Hematology and Oncology
🇺🇸Asheville, North Carolina, United States
Haywood Infusion Center
🇺🇸Clyde, North Carolina, United States
CareMount Medical
🇺🇸Mount Kisco, New York, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
St. Luke's University Heatlh Network - Warren Hospital
🇺🇸Phillipsburg, New Jersey, United States
Johnston Health Services Corporation - Clayton
🇺🇸Clayton, North Carolina, United States
Duke Cancer Network
🇺🇸Laurinburg, North Carolina, United States
Mercy Health Youngstown dba St Joseph Warren Hospital
🇺🇸Warren, Ohio, United States
St. Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Health Youngstown dba St. Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
St. Luke's University Health Network - Sacred Heart Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Luke's Hospital - Allentown Campus
🇺🇸Allentown, Pennsylvania, United States
Greenville Health System
🇺🇸Spartanburg, South Carolina, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Springfield, Oregon, United States
Northwest Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
St. Luke's Hematology Oncology Specialists
🇺🇸Bethlehem, Pennsylvania, United States
Pinnacle Health Cancer Center
🇺🇸Harrisburg, Pennsylvania, United States
St. Luke's University Heatlh Network
🇺🇸Easton, Pennsylvania, United States
Ortenzio Cancer Center at Pinnacle Health
🇺🇸Mechanicsburg, Pennsylvania, United States
Carolina Blood and Cancer Care Associates, PA
🇺🇸Rock Hill, South Carolina, United States
M. Francisco Gonzalez, MD, PA
🇺🇸Sumter, South Carolina, United States
Wellmont Cancer Institute
🇺🇸Kingsport, Tennessee, United States
Texas Oncology - Southwest Fort Worth
🇺🇸Fort Worth, Texas, United States
Lancaster Cancer Center
🇺🇸Lancaster, Pennsylvania, United States
Texas Oncology-Denton South
🇺🇸Denton, Texas, United States
Wellmont Medical Associates Oncology and Hematology
🇺🇸Bristol, Virginia, United States
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Cancer Specialists of Tidewater/Riverside Cancer Infusion Center
🇺🇸Virginia Beach, Virginia, United States
University of Tennessee/Erlanger Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
Huntington Internal Medicine Group
🇺🇸Huntington, West Virginia, United States
West Virginia University, Mary Babb Randolph Cancer Center
🇺🇸Morgantown, West Virginia, United States
Burnaby Hospital Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
Texas Oncology -Allen
🇺🇸Allen, Texas, United States
Bon Secours Cancer Institute @ St. Francis Medical Center
🇺🇸Midlothian, Virginia, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Texas Oncology - Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
University Medical Center Health System, Southwest Cancer Center
🇺🇸Lubbock, Texas, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Southwest Virginia Regional Cancer Center
🇺🇸Norton, Virginia, United States
Bon Secours Richmond Community Hospital dba Oncology Associates at St. Francis Medical Center
🇺🇸Midlothian, Virginia, United States
Bon Secours St. Francis Medical Center, Inc.
🇺🇸Midlothian, Virginia, United States
Riverside Shore Cancer Center
🇺🇸Nassawadox, Virginia, United States
Delta Hematology/Oncology Associates
🇺🇸Portsmouth, Virginia, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Integrated University Center for Health and Social Services (CIUSSS) of Saguenay-Lac Saint Jean
🇨🇦Chicoutimi, Quebec, Canada
Trillium Health Partners
🇨🇦Mississauga, Ontario, Canada
St. Luke's Cancer Institute - East
🇺🇸Kansas City, Missouri, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Touro Infirmary
🇺🇸New Orleans, Louisiana, United States
Bon Secours Richmond Community Hospital dba Oncologists Associates at St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Bon Secours St. Mary's Hospital, Inc.
🇺🇸Richmond, Virginia, United States
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
University of Maryland St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
Mercy Health Perrysburg Cancer Center
🇺🇸Perrysburg, Ohio, United States
Wellmont Bristol Regional Medical Center
🇺🇸Bristol, Tennessee, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Northwest Georgia Oncology Centers, PC
🇺🇸Roswell, Georgia, United States
Fairview Southdale Medical Oncology Clinic
🇺🇸Edina, Minnesota, United States
Advent Health - Hendersonville
🇺🇸Hendersonville, North Carolina, United States
Mercy Health St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Mercy Health Cancer Center
🇺🇸Toledo, Ohio, United States
Pinnacle Health Cancer Institute
🇺🇸Harrisburg, Pennsylvania, United States
Cancer Center at West Jefferson Medical Center, New Orleans Physician Services, Inc.
🇺🇸Marrero, Louisiana, United States
DLP Maria Parham Medical Center
🇺🇸Henderson, North Carolina, United States
University of North Carolina Regional Physicians Hematology Oncology
🇺🇸High Point, North Carolina, United States
Sutter Roseville Medical Center
🇺🇸Roseville, California, United States
Colorado West Healthcare System, dba Community Hospital
🇺🇸Grand Junction, Colorado, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Tidelands Waccamaw Oncology/Georgrtown Hospital System
🇺🇸Myrtle Beach, South Carolina, United States
Colorado West Healthcare System, dba Grand Valley Oncology
🇺🇸Grand Junction, Colorado, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Bon Secours Richmond Community Hospital dba Oncology Associates at Memorial Regional Medical Center
🇺🇸Mechanicsville, Virginia, United States
Camden Clark Medical Center
🇺🇸Parkersburg, West Virginia, United States
Portsmouth Regional Hospital
🇺🇸Portsmouth, New Hampshire, United States
Peninsula Cancer Institute/Riverside Cancer Infusion Center
🇺🇸Williamsburg, Virginia, United States