NCT05155566

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.

Completed Results posted Last updated 26 January 2024

What this trial tests

trial in Breast Cancer Metastatic in 847 participants. Completed in 12 March 2021.

Timeline

15 May 2019

Primary endpoint
12 March 2021

12 March 2021

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	847
Start date	15 May 2019
Primary completion	12 March 2021
Estimated completion	12 March 2021
Sites	2 locations across Argentina, United Kingdom

Conditions studied

• Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, female only, with Breast Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Rate at Month 6 Primary · 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

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	93.4
Palbociclib + Fulvestrant	91.3

Progression Free Rate at Month 12 Primary · 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 inc

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	80.9
Palbociclib + Fulvestrant	76.3

Progression Free Rate at Month 18 Primary · 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 inc

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	68.8
Palbociclib + Fulvestrant	66.2

Progression Free Rate at Month 24 Primary · 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 inc

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	60.9
Palbociclib + Fulvestrant	56.1

Objective Response Rate Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	69.8
Palbociclib + Fulvestrant	67.3

Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	95.0
Palbociclib + Fulvestrant	96.9

Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	83.0
Palbociclib + Fulvestrant	88.8

Clinical Benefit Rate Primary · 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 d

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	94.2
Palbociclib + Fulvestrant	95.2

Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	24.5
Palbociclib + Fulvestrant	23.2

Survival Rate at Month 6 Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	98.9
Palbociclib + Fulvestrant	99.6

Survival Rate at Month 12 Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	95.0
Palbociclib + Fulvestrant	96.9

Survival Rate at Month 18 Primary · 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.

Group	Value	95% CI
Palbociclib + Aromatase Inhibitor	87.7
Palbociclib + Fulvestrant	91.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.