Trial Outcomes & Findings for Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (NCT NCT04176354)
NCT ID: NCT04176354
Last Updated: 2024-08-23
Results Overview
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
COMPLETED
813 participants
From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
2024-08-23
Participant Flow
Data of participants diagnosed with hormone receptor positive(HR+)/human epidermal growth factor receptor 2negative (HER2-)metastatic breast cancer(MBC),who received palbociclib in combination with aromatase inhibitor(AI)\[letrozole,anastrozole or exemestane\]during 03-February-2015 to 31-August-2018(approximately 3.6years)were observed retrospectively.
Data of participants was retrieved from Flatiron Health Analytic database. Available data was evaluated in 9 months of retrospective observational study.
Participant milestones
| Measure |
Palbociclib + AI
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Overall Study
STARTED
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813
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Overall Study
COMPLETED
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813
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
Baseline characteristics by cohort
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Age, Continuous
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64.5 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
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|
Sex: Female, Male
Female
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813 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
White
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555 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
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63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
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18 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Hispanic or Latino
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23 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other/Unknown
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154 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
|
20.0 Months
Interval 17.3 to 22.2
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SECONDARY outcome
Timeframe: From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Overall Survival (OS): Using Kaplan-Meier Method
|
NA Months
Median and 95% CI could not be estimated as there were less number of participants with the event.
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SECONDARY outcome
Timeframe: From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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Number of Participants With Real World Tumour Response (rwTR)
CR
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67 Participants
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Number of Participants With Real World Tumour Response (rwTR)
PR
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355 Participants
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|
Number of Participants With Real World Tumour Response (rwTR)
SD
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166 Participants
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|
Number of Participants With Real World Tumour Response (rwTR)
PD
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98 Participants
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Number of Participants With Real World Tumour Response (rwTR)
Indeterminate
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17 Participants
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Number of Participants With Real World Tumour Response (rwTR)
Not documented
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110 Participants
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SECONDARY outcome
Timeframe: From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Response Rate
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0.519 Proportion of participants
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SECONDARY outcome
Timeframe: From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method
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16.3 Months
Interval 14.4 to 20.5
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SECONDARY outcome
Timeframe: From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method
|
24.6 Months
Interval 22.0 to 26.4
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SECONDARY outcome
Timeframe: From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Palbociclib + AI
n=813 Participants
Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.
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|---|---|
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Time to First Use of Chemotherapy: Using Kaplan-Meier Method
|
36.6 Months
Interval 32.8 to
Upper limit of 95% CI could not be reached due to less number of participants with event.
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Adverse Events
Palbociclib + AI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER