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Clinical Trials/NCT03159195
NCT03159195
Completed
Not Applicable

TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS

Pfizer1 site in 1 country652 target enrollmentJune 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Neoplasm of Breast
Sponsor
Pfizer
Enrollment
652
Locations
1
Primary Endpoint
Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.

Registry
clinicaltrials.gov
Start Date
June 12, 2017
End Date
June 24, 2021
Last Updated
10 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation

Time Frame: 1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)

Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 1 year post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.

Percentage of Participants With Progression Free Survival (PFS) at Month 12

Time Frame: Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)

PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) 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, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.

Percentage of Participants With Progression Free Survival at Month 24

Time Frame: Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)

PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) 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, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 24 months based on the Kaplan-Meier estimate were reported.

Percentage of Participants With Objective Response Rate (ORR)

Time Frame: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)

ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: 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 2 Years Post Palbociclib Treatment Initiation

Time Frame: 2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)

Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 2 years post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.

Study Sites (1)

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