The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
99
As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Sunagawa City Medical Center
Sunagawa, Hokkaido, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Sakai City Medical Center
Sakai, Osaka, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
...and 10 more locations
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 1 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 2 (1 cycle = 4 weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 3 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 4 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 5 (1 cycle = 4 Weeks)
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Time frame: Baseline, Cycle 6 (1 cycle = 4 Weeks)
Change From Baseline in Sedentary Time Wearing at Week 1
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 1
Change From Baseline in Sedentary Time Wearing at Week 2
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 2
Change From Baseline in Sedentary Time Wearing at Week 3
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 3
Change From Baseline in Sedentary Time Wearing at Week 4
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 4
Change From Baseline in Sedentary Time Wearing at Week 5
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 5
Change From Baseline in Sedentary Time Wearing at Week 6
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 6
Change From Baseline in Sedentary Time Wearing at Week 7
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 7
Change From Baseline in Sedentary Time Wearing at Week 8
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 8
Change From Baseline in Sedentary Time Wearing at Week 9
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 9
Change From Baseline in Sedentary Time Wearing at Week 10
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 10
Change From Baseline in Sedentary Time Wearing at Week 11
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 11
Change From Baseline in Sedentary Time Wearing at Week 12
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 12
Change From Baseline in Sedentary Time Wearing at Week 13
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 13
Change From Baseline in Sedentary Time Wearing at Week 14
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 14
Change From Baseline in Sedentary Time Wearing at Week 15
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 15
Change From Baseline in Sedentary Time Wearing at Week 16
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 16
Change From Baseline in Sedentary Time Wearing at Week 17
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 17
Change From Baseline in Sedentary Time Wearing at Week 18
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 18
Change From Baseline in Sedentary Time Wearing at Week 19
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 19
Change From Baseline in Sedentary Time Wearing at Week 20
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 20
Change From Baseline in Sedentary Time Wearing at Week 21
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 21
Change From Baseline in Sedentary Time Wearing at Week 22
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 22
Change From Baseline in Sedentary Time Wearing at Week 23
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 23
Change From Baseline in Sedentary Time Wearing at Week 24
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Time frame: Baseline, Week 24
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical \[P\], role \[R\], emotional \[E\], cognitive \[C\], and social \[S\] functioning \[F\]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Total estimated steps taken per week were reported in this outcome measure.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure.
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Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events
AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement.
Time frame: From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Fatigue Interference Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Severity Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Interference Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Number of Participants According to Pain Frequency Based on PRO-CTCAE
The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly.
Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)
Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (\>) 25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled
Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
MVPA Before and After Disease Progression: Group 1 and 2 Pooled
Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical \[P\],role \[R\],emotional \[E\],cognitive \[C\], and social \[S\] functioning \[F\], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as \>25% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)
Number of Participants With Treatment Satisfaction
Treatment satisfaction was evaluated with single item question (eg,"How satisfied are you with your current breast cancer treatment?") using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied).
Time frame: Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)
Number of Participants According to Starting Dose of Palbociclib Treatment
Number of participants according to starting dose of palbociclib treatment (125 milligrams \[mg\], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start.
Time frame: Baseline
Number of Participants Who Had Any Palbociclib Dose Reduction
Time frame: Up to 24 Weeks
Number of Participants Who Had Any Palbociclib Dose Interruption
Time frame: Up to 24 Weeks
Number of Participants With Cycle Delay in Palbociclib Treatment
Time frame: Up to 24 Weeks