Breast Cancer
Conditions
Brief summary
The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line treatment in the US community oncology setting.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female or male sex. * Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis. * Age ≥18 years at A/MBC diagnosis. * Initiated palbociclib in combination with an AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019. Note that the date of the start of the inclusion period reflects the month of palbociclib US FDA approval. * Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present). * Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).
Exclusion criteria
* Enrollment in an interventional clinical trial for A/MBC during the study observation period. * Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting. * Evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Regimen Distribution | From start of treatment to end of follow-up, up to a maximum of approximately 5 years | Regimen medications were defined as systemic therapies included in line regimen based on synapse line of therapy algorithm. Treatment regimen distribution included: first-line regimen; palbociclib along with aromatase inhibitor and second-line regimen; CDK4/6 inhibitor plus endocrine and chemotherapy. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression. |
| Percentage of Participants With Sequence of Treatment Lines | From start of treatment to end of follow-up, up to a maximum of approximately 5 years | Line of therapy was defined as line number (1; 2; 3; etc.) in the A/MBC setting assigned based on synapse line of therapy algorithm. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression. |
| Percentage of Participants With Their Starting Dose and End Dose | From start of treatment to end of follow-up, up to a maximum of approximately 5 years | Percentage of participants with starting and end dose at 125 mg, 100 mg, 75 mg and unknown were reported. |
| Percentage of Participants With Type of Dose Adjustment | From start of treatment to end of follow-up, up to a maximum of approximately 5 years | In this outcome measure type of dose adjustments were recorded and reported. It included dose increase, decrease, no adjustment and unknown categories. |
| Percentage of Participants With Their Reason For Treatment Discontinuation | From start of treatment to end of follow-up, up to a maximum of approximately 5 years | Percentage of participants with discontinuation reason as progression, intolerance/toxicity, participant choice, treatment for other diseases, left health system, end of planned therapy, changes in insurance, death, hospice referral, physician choice, actionable mutation found, other/unknown were recorded and reported in this outcome measure. |
| Time to Dose Adjustment | From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years | Time to dose adjustment (TTDA) was defined as the time from the start of palbociclib and AI treatment until the date of treatment dose adjustment. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 3 | 3 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as disease progression \[PD\] or death due to any cause) at 3 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 6 | 6 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 6 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 12 | 12 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 12 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 18 | 18 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 18 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 24 | 24 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 24 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 30 | 30 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 30 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Progression-Free Survival (rwPFS) at Month 36 | 36 months after treatment initiation any time during 5 years of study period | Probability of being event free (event defined as PD or death due to any cause) at 36 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 3 | 3 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 6 | 6 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 12 | 12 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 18 | 18 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 24 | 24 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 30 | 30 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Real-World Overall Survival (rwOS) at Month 36 | 36 months after treatment initiation any time during 5 years of study period | rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3 | 3 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 3 were reported in this outcome measure. Real-world time to treatment discontinuation (rwTTD) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6 | 6 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 6 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12 | 12 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 12 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18 | 18 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 18 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24 | 24 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 24 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30 | 30 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 30 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36 | 36 months after treatment initiation any time during 5 years of study period | Probability of participants without first-line treatment discontinuation or death at month 36 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3 | 3 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 3 were reported in this outcome measure. Real-world time to next treatment (rwTTNT) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6 | 6 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 6 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12 | 12 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 12 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18 | 18 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 18 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24 | 24 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 24 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30 | 30 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 30 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36 | 36 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent line of therapy initiation or death at month 36 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 3 | 3 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 3 were reported in this outcome measure. Real-world time to chemotherapy (rwTTC) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 6 | 6 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 6 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 12 | 12 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 12 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 18 | 18 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 18 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 24 | 24 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 24 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 30 | 30 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 30 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without Subsequent Chemotherapy or Death at Month 36 | 36 months after treatment initiation any time during 5 years of study period | Probability of participants without subsequent chemotherapy or death at month 36 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3 | 3 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 3 were reported in this outcome measure. Real-world time to dose adjustment (rwTTDA) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6 | 6 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 6 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12 | 12 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 12 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18 | 18 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 18 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24 | 24 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 24 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30 | 30 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 30 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
| Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36 | 36 months after treatment initiation any time during 5 years of study period | Probability of participants without a first-line therapy dose adjustment at month 36 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method. |
Countries
United States
Participant flow
Recruitment details
Participants who received palbociclib with aromatase inhibitor(AI) as first-line therapy on or after 03 February 2015 through 31 July 2019 were observed retrospectively; data cutoff was 01 February 2020, resulting in a minimum potential 6-month follow-up period. The data was abstracted from charts during a 6 month period of time from 30 June 2020 to 31 December 2020.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib With Aromatase Inhibitor Participants with advanced/metastatic breast cancer (A/MBC), hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative disease, received palbociclib capsule orally once daily with AI as first-line therapy were observed retrospectively during the study. The data of these participants were studied in this observational study. | 242 |
| Total | 242 |
Baseline characteristics
| Characteristic | Palbociclib With Aromatase Inhibitor |
|---|---|
| Age at A/MBC Diagnosis | 64.68 Years STANDARD_DEVIATION 12.22 |
| Age at Death Between 50-64 years | 9.9 Percentage of participants |
| Age at Death Between 65-74 years | 5.4 Percentage of participants |
| Age at Death Greater than or equal to (>=) 75 years | 8.7 Percentage of participants |
| Age at Death Less than (<) 50 years | 1.7 Percentage of participants |
| Age at Death Missing | 74.0 Percentage of participants |
| Age, Continuous | 60.39 Years STANDARD_DEVIATION 13.72 |
| Disease Free Interval | 64.00 Months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Insurance Carrier at A/MBC Diagnosis Commercial | 28.5 Percentage of Participants |
| Insurance Carrier at A/MBC Diagnosis Medicare/Medicaid | 61.6 Percentage of Participants |
| Insurance Carrier at A/MBC Diagnosis None | 1.2 Percentage of Participants |
| Insurance Carrier at A/MBC Diagnosis Not Stated in Participant Record | 8.7 Percentage of Participants |
| Menopausal Status at A/MBC Diagnosis Not Applicable | 1.7 Percentage of participants |
| Menopausal Status at A/MBC Diagnosis Not Stated in Participant Record | 2.1 Percentage of participants |
| Menopausal Status at A/MBC Diagnosis Peri-menopausal | 0.8 Percentage of participants |
| Menopausal Status at A/MBC Diagnosis Post-menopausal | 85.5 Percentage of participants |
| Menopausal Status at A/MBC Diagnosis Pre-menopausal | 9.9 Percentage of participants |
| Percentage of Participants With Any Prior Surgery No | 47.5 Percentage of participants |
| Percentage of Participants With Any Prior Surgery Yes | 52.5 Percentage of participants |
| Percentage of Participants With Breast Cancer Susceptibility Gene (BRCA) 1 or 2 Testing Status No | 81.0 Percentage of participants |
| Percentage of Participants With Breast Cancer Susceptibility Gene (BRCA) 1 or 2 Testing Status Yes | 19.0 Percentage of participants |
| Percentage of Participants With Charlson Comorbidity Index Score 0 | 65.3 Percentage of participants |
| Percentage of Participants With Charlson Comorbidity Index Score 1 | 19.4 Percentage of participants |
| Percentage of Participants With Charlson Comorbidity Index Score 2 | 9.1 Percentage of participants |
| Percentage of Participants With Charlson Comorbidity Index Score 3 | 3.7 Percentage of participants |
| Percentage of Participants With Charlson Comorbidity Index Score 4+ | 2.5 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Anemia | 4.5 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Cardiac Arrhythmias | 2.9 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Cerebrovascular Disease | 0.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Chronic Pulmonary Disease | 5.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Congestive Heart Failure | 4.1 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Dementia | 0.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Diabetes | 21.9 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Hypertension | 48.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Liver Disease | 0.4 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Myocardial Infarction | 0.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden None of the Above | 36.8 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Not Stated in Participant Record | 1.2 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Peripheral Vascular Disease | 1.2 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Renal Disease | 9.1 Percentage of participants |
| Percentage of Participants With Comorbid Disease Burden Rheumatic Disease | 1.2 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Bone Multiple Sites | 64.5 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Bone No Metastases at Site | 16.9 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Bone Single Site | 16.9 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Bone Unknown Number of Sites | 1.7 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Liver Multiple Lesions | 5.8 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Liver No Metastases at Site | 90.1 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Liver Single Lesion | 3.3 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Liver Unknown Number of Lesions | 0.8 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Lung Bilateral Lungs | 13.2 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Lung No Metastases at Site | 78.5 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Lung Single Lung | 5.4 Percentage of participants |
| Percentage of Participants With Disease Burden at Metastatic Sites in Lung Unknown Single vs Bilateral Status | 2.9 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- 0 | 23.6 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- 1 | 24.0 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- 1-2 | 0.4 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- 2 | 8.3 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- 3 | 3.3 Percentage of participants |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG- Not Stated in Participant Record | 40 Percentage of participants |
| Percentage of Participants With Endocrine Sensitivity and Endocrine Resistance Endocrine Sensitivity | 84.9 Percentage of participants |
| Percentage of Participants With Endocrine Sensitivity and Endocrine Resistance Primary Endocrine Resistance | 28.5 Percentage of participants |
| Percentage of Participants With Endocrine Sensitivity and Endocrine Resistance Secondary Endocrine Resistance | 45.5 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status HER2 Status: equivocal | 2.1 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status HER2 Status: HER2 negative | 97.9 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status Hormone Receptor Status: ER+ / Not Applicable (NA) | 0.8 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status Hormone Receptor Status: ER- / PR- | 0.4 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status Hormone Receptor Status: ER- / PR+ | 0.4 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status Hormone Receptor Status: ER+ / PR- | 18.6 Percentage of participants |
| Percentage of Participants With HER2 and Estrogen Receptor (ER) or Progesterone Receptor (PR) Status Hormone Receptor Status: ER+ / PR+ | 79.8 Percentage of participants |
| Percentage of Participants With Histology Type DCIS | 0.8 Percentage of participants |
| Percentage of Participants With Histology Type Invasive Ductal Carcinoma | 56.6 Percentage of participants |
| Percentage of Participants With Histology Type Invasive Lobular Carcinoma | 22.3 Percentage of participants |
| Percentage of Participants With Histology Type Invasive Mixed (ductal and lobular) | 4.5 Percentage of participants |
| Percentage of Participants With Histology Type Other | 15.7 Percentage of participants |
| Percentage of Participants With Modalities of Treatment Received Prior to A/MBC Chemotherapy | 12.1 Percentage of participants |
| Percentage of Participants With Modalities of Treatment Received Prior to A/MBC Endocrine Therapy | 7.1 Percentage of participants |
| Percentage of Participants With Modalities of Treatment Received Prior to A/MBC Targeted Therapy | 1.0 Percentage of participants |
| Percentage of Participants With Number of Metastatic Sites 1 | 60.7 Percentage of participants |
| Percentage of Participants With Number of Metastatic Sites 2 | 18.6 Percentage of participants |
| Percentage of Participants With Number of Metastatic Sites >=3 | 20.2 Percentage of participants |
| Percentage of Participants With Number of Metastatic Sites Participant is Not Metastatic | 0.4 Percentage of participants |
| Percentage of Participants With Radiation Therapy No | 67.4 Percentage of participants |
| Percentage of Participants With Radiation Therapy Yes | 32.6 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Chest Wall | 5.0 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Chest Wall, Regional Lymph Nodes | 7.4 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Partial Breast | 0.8 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Unknown (site not known) | 7.4 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Whole Breast | 7.4 Percentage of participants |
| Percentage of Participants With Radiation Therapy Sites Whole Breast, Regional Lymph Nodes | 5.0 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Adrenal | 1.7 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Bone (Bone only or in addition to other sites) | 83.1 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Bone Marrow | 1.7 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Bone Only | 50.8 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Chest Wall | 0.0 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis CNS | 2.5 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Colon | 0.8 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Contralateral Breast | 0.8 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Distant Lymph Node (s) | 18.6 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Liver | 9.9 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Lung | 21.5 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Malignant Pleural Effusion | 10.3 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Omentum | 0.4 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Other: Specify | 7.4 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Ovary | 0.4 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Peritoneum | 2.1 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Pleural Nodules | 5 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Skin | 3.7 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Soft Tissue | 2.5 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Stomach | 1.2 Percentage of participants |
| Percentage of Participants With Sites of Distant Metastasis Visceral Sites | 32.2 Percentage of participants |
| Percentage of Participants With Time to Metastasis <= 12 Months | 5.7 Percentage of participants |
| Percentage of Participants With Time to Metastasis 13-24 Months | 3.8 Percentage of participants |
| Percentage of Participants With Time to Metastasis 25-36 Months | 8.6 Percentage of participants |
| Percentage of Participants With Time to Metastasis > 36 Months | 81.9 Percentage of participants |
| Percentage of Participants With Types of Surgery Breast Conserving Surgery | 20.2 Percentage of participants |
| Percentage of Participants With Types of Surgery Mastectomy | 32.2 Percentage of participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 196 Participants |
| Region of Residence at A/MBC Diagnosis North Central | 95.0 Percentage of participants |
| Region of Residence at A/MBC Diagnosis Northeast | 0.4 Percentage of participants |
| Region of Residence at A/MBC Diagnosis South | 4.1 Percentage of participants |
| Region of Residence at A/MBC Diagnosis West | 0.4 Percentage of participants |
| Sex: Female, Male Female | 238 Participants |
| Sex: Female, Male Male | 4 Participants |
| Stage at Initial Breast Cancer Diagnosis 0 | 0.8 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis I | 2.9 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IA | 1.2 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis II | 6.6 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IIA | 8.3 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IIB | 9.5 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis III | 2.5 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IIIA | 5.0 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IIIB | 0.4 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IIIC | 0.8 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis IV | 55.4 Percentage of participants |
| Stage at Initial Breast Cancer Diagnosis Not Stated in Participant Record | 7 Percentage of participants |
| Year of A/MBC Diagnoses | 2017 Year |
| Year of Initial Diagnoses | 2016 Years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 62 / 242 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Sequence of Treatment Lines
Line of therapy was defined as line number (1; 2; 3; etc.) in the A/MBC setting assigned based on synapse line of therapy algorithm. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Sequence of Treatment Lines | 1 Line | 100 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Sequence of Treatment Lines | 2 Lines | 21.49 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Sequence of Treatment Lines | 3 Lines | 12.81 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Sequence of Treatment Lines | 4 Lines | 2.07 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Sequence of Treatment Lines | 5 Lines or more | 3.31 Percentage of participants |
Primary
Percentage of Participants With Their Reason For Treatment Discontinuation
Percentage of participants with discontinuation reason as progression, intolerance/toxicity, participant choice, treatment for other diseases, left health system, end of planned therapy, changes in insurance, death, hospice referral, physician choice, actionable mutation found, other/unknown were recorded and reported in this outcome measure.
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Population: Analysis population (AP) included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Progression | 26.4 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Intolerance/toxicity | 14.9 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Participant Choice | 2.5 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Treatment for Other Diseases | 2.5 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Left Health System | 0 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | End of Planned Therapy | 2.1 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Changes in Insurance | 1.2 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Death | 1.2 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Hospice Referral | 1.2 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Physician Choice | 0.8 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Actionable Mutation Found | 0.4 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Reason For Treatment Discontinuation | Other/Unknown | 2.9 Percentage of participants |
Primary
Percentage of Participants With Their Starting Dose and End Dose
Percentage of participants with starting and end dose at 125 mg, 100 mg, 75 mg and unknown were reported.
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | Starting Dose: 125 mg | 89.7 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | Starting Dose: 100 mg | 7.4 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | Starting Dose: 75 mg | 1.2 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | Starting Dose: Unknown | 1.7 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | End Dose: 125 mg | 60.7 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | End Dose: 100 mg | 27.7 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | End Dose: 75 mg | 9.9 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Their Starting Dose and End Dose | End Dose: Unknown | 1.7 Percentage of participants |
Primary
Percentage of Participants With Treatment Regimen Distribution
Regimen medications were defined as systemic therapies included in line regimen based on synapse line of therapy algorithm. Treatment regimen distribution included: first-line regimen; palbociclib along with aromatase inhibitor and second-line regimen; CDK4/6 inhibitor plus endocrine and chemotherapy. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Treatment Regimen Distribution | First-line regimen | 100 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Treatment Regimen Distribution | Second-line regimen | 39.67 Percentage of participants |
Primary
Percentage of Participants With Type of Dose Adjustment
In this outcome measure type of dose adjustments were recorded and reported. It included dose increase, decrease, no adjustment and unknown categories.
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Type of Dose Adjustment | Increase | 0.4 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Type of Dose Adjustment | Decrease | 31.0 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Type of Dose Adjustment | No adjustment | 66.9 Percentage of participants |
| Palbociclib With Aromatase Inhibitor | Percentage of Participants With Type of Dose Adjustment | Unknown | 1.7 Percentage of participants |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12
Probability of participants without a first-line therapy dose adjustment at month 12 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12 | 0.73 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18
Probability of participants without a first-line therapy dose adjustment at month 18 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18 | 0.69 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24
Probability of participants without a first-line therapy dose adjustment at month 24 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24 | 0.68 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3
Probability of participants without a first-line therapy dose adjustment at month 3 were reported in this outcome measure. Real-world time to dose adjustment (rwTTDA) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3 | 0.82 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30
Probability of participants without a first-line therapy dose adjustment at month 30 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30 | 0.67 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36
Probability of participants without a first-line therapy dose adjustment at month 36 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36 | 0.65 Probability |
Primary
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6
Probability of participants without a first-line therapy dose adjustment at month 6 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6 | 0.76 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12
Probability of participants without first-line treatment discontinuation or death at month 12 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12 | 0.67 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18
Probability of participants without first-line treatment discontinuation or death at month 18 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18 | 0.56 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24
Probability of participants without first-line treatment discontinuation or death at month 24 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24 | 0.49 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3
Probability of participants without first-line treatment discontinuation or death at month 3 were reported in this outcome measure. Real-world time to treatment discontinuation (rwTTD) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3 | 0.93 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30
Probability of participants without first-line treatment discontinuation or death at month 30 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30 | 0.41 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36
Probability of participants without first-line treatment discontinuation or death at month 36 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36 | 0.36 Probability |
Primary
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6
Probability of participants without first-line treatment discontinuation or death at month 6 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6 | 0.84 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 12
Probability of participants without subsequent chemotherapy or death at month 12 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 12 | 0.83 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 18
Probability of participants without subsequent chemotherapy or death at month 18 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 18 | 0.74 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 24
Probability of participants without subsequent chemotherapy or death at month 24 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 24 | 0.69 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 3
Probability of participants without subsequent chemotherapy or death at month 3 were reported in this outcome measure. Real-world time to chemotherapy (rwTTC) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 3 | 0.98 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 30
Probability of participants without subsequent chemotherapy or death at month 30 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 30 | 0.63 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 36
Probability of participants without subsequent chemotherapy or death at month 36 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 36 | 0.58 Probability |
Primary
Probability of Participants Without Subsequent Chemotherapy or Death at Month 6
Probability of participants without subsequent chemotherapy or death at month 6 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Chemotherapy or Death at Month 6 | 0.93 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12
Probability of participants without subsequent line of therapy initiation or death at month 12 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12 | 0.73 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18
Probability of participants without subsequent line of therapy initiation or death at month 18 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18 | 0.62 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24
Probability of participants without subsequent line of therapy initiation or death at month 24 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24 | 0.55 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3
Probability of participants without subsequent line of therapy initiation or death at month 3 were reported in this outcome measure. Real-world time to next treatment (rwTTNT) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3 | 0.97 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30
Probability of participants without subsequent line of therapy initiation or death at month 30 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30 | 0.47 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36
Probability of participants without subsequent line of therapy initiation or death at month 36 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36 | 0.41 Probability |
Primary
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6
Probability of participants without subsequent line of therapy initiation or death at month 6 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6 | 0.89 Probability |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 12
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 12 | 0.9 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 18
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 18 | 0.84 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 24
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 24 | 0.78 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 3
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 3 | 0.99 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 30
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 30 | 0.73 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 36
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 36 | 0.69 Probability of being alive |
Primary
Probability of Real-World Overall Survival (rwOS) at Month 6
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Overall Survival (rwOS) at Month 6 | 0.97 Probability of being alive |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 12
Probability of being event free (event defined as PD or death due to any cause) at 12 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 12 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 12 | 0.75 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 18
Probability of being event free (event defined as PD or death due to any cause) at 18 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 18 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 18 | 0.66 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 24
Probability of being event free (event defined as PD or death due to any cause) at 24 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 24 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 24 | 0.59 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 3
Probability of being event free (event defined as disease progression \[PD\] or death due to any cause) at 3 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 3 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 3 | 0.95 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 30
Probability of being event free (event defined as PD or death due to any cause) at 30 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 30 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 30 | 0.53 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 36
Probability of being event free (event defined as PD or death due to any cause) at 36 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 36 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 36 | 0.48 Probability of being event free |
Primary
Probability of Real-World Progression-Free Survival (rwPFS) at Month 6
Probability of being event free (event defined as PD or death due to any cause) at 6 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Time frame: 6 months after treatment initiation any time during 5 years of study period
Population: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Probability of Real-World Progression-Free Survival (rwPFS) at Month 6 | 0.84 Probability of being event free |
Primary
Time to Dose Adjustment
Time to dose adjustment (TTDA) was defined as the time from the start of palbociclib and AI treatment until the date of treatment dose adjustment.
Time frame: From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years
Population: AP: all participants who met following criteria: 1)Diagnosis of A/MBC;2)Aged \>=18years at A/MBC diagnosis;3)Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on/after 03 February 2015-31 July 2019;4)Evidence of ER/PR positive disease and HER2 negative disease/absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palbociclib With Aromatase Inhibitor | Time to Dose Adjustment | 55.0 Days |