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Malignant Neoplasm of Breast Clinical Trial

— IRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159195
• Other study ID #: A5481090
• Secondary ID: IRIS
• Status: Completed
• Start date: June 12, 2017
• Est. completion date: June 24, 2021

Study information

• Verified date: May 2022
• 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 in line with regional licensed indications in real world settings across multiple countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: June 24, 2021
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Physician inclusion criteria

• Oncologist or gynecologist

• Responsible for treating a minimum of =2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.

• Agrees to participate in the study and complete the eCRFs within the data collection period.

Patient inclusion criteria

• Female

• =18 years old.

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.

• Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).

• No prior or current enrolment in an interventional clinical trial for ABC/MBC.

• Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).

• Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).

• Inoperable or recurrent breast cancer (Japan only)

Exclusion criteria:

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 in line with the licenced indication(s).

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of Breast
• Neoplasms

Locations

Country	Name	City	State
United States	Pfizer, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Clinical Benefit Rate (CBR)	CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. 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.	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
Other	Percentage of Participants With Best Overall Response	Best overall response was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment), partial response (where 'partial response' was recorded at any time on treatment) and stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
Primary	Percentage of Participants With Progression Free Survival (PFS) at Month 12	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.	Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)
Primary	Percentage of Participants With Progression Free Survival at Month 24	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.	Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)
Primary	Percentage of Participants With Objective Response Rate (ORR)	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.	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)
Primary	Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation	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.	1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)
Primary	Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation	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.	2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)

External Links

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