Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
- Conditions
- Breast Cancer Metastatic
- Registration Number
- NCT05155566
- Lead Sponsor
- Pfizer
- Brief Summary
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 847
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Time From Palbociclib Initiation to Complete Response From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) CR was defined as complete resolution of all visible disease per the treating physicians opinion.
Duration of Ongoing Palbociclib Treatment Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Progression Free Rate at Month 6 Month 6 (from the data collected and observed retrospectively for approximately 22 months) Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Objective Response Rate From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months) Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.
Clinical Benefit Rate From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.
Survival Rate at Month 18 Month 18 (from the data collected and observed retrospectively for approximately 22 months) Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Number of Participants With Supportive Therapies From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Number of participants who received supportive therapies during palbociclib treatment were reported.
Number of Participants According to Therapies Received Post Palbociclib Treatment Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Number of participants who received therapies post palbociclib treatment were reported.
Progression Free Rate at Month 12 Month 12 (from the data collected and observed retrospectively for approximately 22 months) Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Survival Rate at Month 24 Month 24 (from the data collected and observed retrospectively for approximately 22 months) Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Survival Rate at Month 6 Month 6 (from the data collected and observed retrospectively for approximately 22 months) Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time From Palbociclib Initiation to Initial Response Recorded From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Duration of Discontinued Palbociclib Treatment Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Progression Free Rate at Month 18 Month 18 (from the data collected and observed retrospectively for approximately 22 months) Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Progression Free Rate at Month 24 Month 24 (from the data collected and observed retrospectively for approximately 22 months) Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Survival Rate at Month 12 Month 12 (from the data collected and observed retrospectively for approximately 22 months) Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time From Palbociclib Initiation to Partial Response From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Follow-up Time Since Palbociclib Initiation From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Duration of Dose Interruption Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Duration of Cycle Delays Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months) Time From Palbociclib Initiation to First Dose Reduction Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Pfizer country office
🇦🇷Buenos Aires, Argentina
Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK
🇬🇧Bollington, Chesshire, United Kingdom