Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy

NCT04394247 | Completed Results

• 1 other identifier: A5481155
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (48)

• 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.

  From start of treatment to end of follow-up, up to a maximum of approximately 5 years

• 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.

  From start of treatment to end of follow-up, up to a maximum of approximately 5 years

• 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.

  From start of treatment to end of follow-up, up to a maximum of approximately 5 years

• 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.

  From start of treatment to end of follow-up, up to a maximum of approximately 5 years

• 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.

  From start of treatment to end of follow-up, up to a maximum of approximately 5 years

• 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.

  From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years

• 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.

  3 months after treatment initiation any time during 5 years of study period

• 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.

  6 months after treatment initiation any time during 5 years of study period

• 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.

  12 months after treatment initiation any time during 5 years of study period

• 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.

  18 months after treatment initiation any time during 5 years of study period

• 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.

  24 months after treatment initiation any time during 5 years of study period

• 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.

  30 months after treatment initiation any time during 5 years of study period

• 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.

  36 months after treatment initiation any time during 5 years of study period

• 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.

  3 months after treatment initiation any time during 5 years of study period

• 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.

  6 months after treatment initiation any time during 5 years of study period

• 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.

  12 months after treatment initiation any time during 5 years of study period

• 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.

  18 months after treatment initiation any time during 5 years of study period

• 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.

  24 months after treatment initiation any time during 5 years of study period

• 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.

  30 months after treatment initiation any time during 5 years of study period

• 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  36 months after treatment initiation any time during 5 years of study period

• 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.

  3 months after treatment initiation any time during 5 years of study period

• 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.

  6 months after treatment initiation any time during 5 years of study period

• 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.

  12 months after treatment initiation any time during 5 years of study period

• 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.

  18 months after treatment initiation any time during 5 years of study period

• 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.

  24 months after treatment initiation any time during 5 years of study period

• 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.

  30 months after treatment initiation any time during 5 years of study period

• 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  36 months after treatment initiation any time during 5 years of study period

Study Arms (1)

Breast Cancer Patients

HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

Eligibility Criteria

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

Study Population

The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated palbociclib combination therapy with AI as the first-line therapy on or after 03 February 2015 up to and including 31 July 2019.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Syapse

San Francisco, California, 94107, United States

Location

Related Publications (1)

• Law JW, Mitra D, Kaplan HG, Alfred T, Brufsky AM, Emir B, McCracken H, Liu X, Broome RG, Zhang C, DiCristo C, Chen C. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Curr Oncol. 2022 Feb 12;29(2):1047-1061. doi: 10.3390/curroncol29020089.

  PMID: 35200588 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: June 30, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)