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.

Breast Cancer Metastatic Clinical Trial

Official title:

Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155566
• Other study ID #: A5481125
• Secondary ID: IRIS LATAM
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: March 12, 2021

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Physician inclusion criteria:

• Oncologist or gynecologist.
• Responsible for treating =4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
• Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.

Patient inclusion criteria:

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
• Received palbociclib as a first line therapy.
• No prior or current enrolment in an interventional clinical trial for ABC/MBC.
• Minimum of six months of follow up data since palbociclib initiation.

Physician exclusion criteria:

• Qualified less than 2 years ago or more than 35 years ago.
• Participated in observational research for ABC/MBC in the last 3 months.
• Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Neoplasms

Locations

Country	Name	City	State
Argentina	Pfizer country office	Buenos Aires
United Kingdom	Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK	Bollington	Chesshire

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Rate at Month 6	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.	Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Progression Free Rate at Month 12	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.	Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Progression Free Rate at Month 18	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.	Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Progression Free Rate at Month 24	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.	Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Objective Response Rate	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.	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)
Primary	Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation	Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.	1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Primary	Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation	Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.	2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Primary	Clinical Benefit Rate	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.	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)
Primary	Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib	SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.	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)
Primary	Survival Rate at Month 6	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.	Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Survival Rate at Month 12	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.	Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Survival Rate at Month 18	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.	Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Survival Rate at Month 24	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.	Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Primary	Time From Palbociclib Initiation to Initial Response Recorded	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.	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)
Primary	Time From Palbociclib Initiation to Complete Response	CR was defined as complete resolution of all visible disease per the treating physicians opinion.	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)
Primary	Time From Palbociclib Initiation to Partial Response	PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.	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)
Primary	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)
Primary	Number of Participants With Supportive Therapies	Number of participants who received supportive therapies during palbociclib treatment were reported.	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)
Primary	Duration of Ongoing Palbociclib Treatment		Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Primary	Duration of Discontinued Palbociclib Treatment		Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Primary	Number of Participants According to Therapies Received Post Palbociclib Treatment	Number of participants who received therapies post palbociclib treatment were reported.	Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Primary	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)
Primary	Duration of Dose Interruption		Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Primary	Duration of Cycle Delays		Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)

External Links

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