| Primary | Progression Free Rate at Month 6 | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 6 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Progression Free Rate at Month 12 | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 12 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant |
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| Primary | Progression Free Rate at Month 18 | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 18 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant |
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| Primary | Progression Free Rate at Month 24 | Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 24 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant |
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| Primary | Objective Response Rate | Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation | Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation | Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Clinical Benefit Rate | Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) >=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib | SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Survival Rate at Month 6 | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 6 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Survival Rate at Month 12 | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 12 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Survival Rate at Month 18 | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 18 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Survival Rate at Month 24 | Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Month 24 (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Time From Palbociclib Initiation to Initial Response Recorded | CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Time From Palbociclib Initiation to Complete Response | CR was defined as complete resolution of all visible disease per the treating physicians opinion. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Time From Palbociclib Initiation to Partial Response | PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Follow-up Time Since Palbociclib Initiation | | FAS comprised of participants for whom a complete medical record review was conducted. | Posted | | Median | Full Range | Months | | From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Number of Participants With Supportive Therapies | Number of participants who received supportive therapies during palbociclib treatment were reported. | FAS comprised of participants for whom a complete medical record review was conducted. Participants could receive more than one supportive treatment. | Posted | | Count of Participants | | Participants | | From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Duration of Ongoing Palbociclib Treatment | | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Duration of Discontinued Palbociclib Treatment | | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Number of Participants According to Therapies Received Post Palbociclib Treatment | Number of participants who received therapies post palbociclib treatment were reported. | FAS comprised of participants for whom a complete medical record review was conducted. | Posted | | Count of Participants | | Participants | | Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Time From Palbociclib Initiation to First Dose Reduction | | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Duration of Dose Interruption | | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Days | | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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| Primary | Duration of Cycle Delays | | FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Days | | Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) | | | | ID | Title | Description |
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| OG000 | Palbociclib + Aromatase Inhibitor | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study. | | OG001 | Palbociclib + Fulvestrant | Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study. |
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