Ibrance Real World Insights

NCT03159195 | Completed Results

• 2 other identifiers: A5481090IRIS
• Study Type: observational
• Target: 652
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm of Breast

Keywords

metastatic breast cancer; advanced breast cancer; HR+/ HER2-

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Percentage of Participants With Clinical Benefit Rate (CBR)

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

• Percentage of Participants With Best Overall Response

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

Study Arms (1)

Breast Cancer Patients

HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female participants only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication.

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer, Inc.

New York, New York, 10017, United States

Location

Related Publications (3)

• Mycock K, Zhan L, Hart K, Taylor-Stokes G, Milligan G, Atkinson C, Mitra D. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib combinations for HR+/HER2- advanced/metastatic breast cancer in Japan: Results from the IRIS study. Cancer Treat Res Commun. 2022;32:100573. doi: 10.1016/j.ctarc.2022.100573. Epub 2022 May 6.

  PMID: 35567914 DERIVED

• Mycock K, Zhan L, Taylor-Stokes G, Milligan G, Mitra D. Real-World Palbociclib Use in HR+/HER2- Advanced Breast Cancer in Canada: The IRIS Study. Curr Oncol. 2021 Jan 24;28(1):678-688. doi: 10.3390/curroncol28010066.

  PMID: 33498797 DERIVED

• Waller J, Mitra D, Mycock K, Taylor-Stokes G, Milligan G, Zhan L, Iyer S. Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. J Glob Oncol. 2019 May;5:JGO1800239. doi: 10.1200/JGO.18.00239.

  PMID: 31050919 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: June 12, 2017
• Primary Completion: July 23, 2020
• Study Completion: June 24, 2021
• Last Updated: July 1, 2025
• Results First Posted: September 17, 2021

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)