Malignant Neoplasm of BreastIRISNCT03159195

Ibrance Real World Insights

An observational study of Malignant Neoplasm of Breast, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Malignant Neoplasm of Breast
How many people: 652 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2017to 24 Jun 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer, Inc.
New York, New York, 10017

Other trials in United States

About this study

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

Conditions: Malignant Neoplasm of Breast
Keywords: metastatic breast cancer, advanced breast cancer, HR+/ HER2-
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03159195
Study group	Role	What they receive
Breast Cancer Patients		HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201724 Jun 2021

First posted18 May 2017
Study start12 Jun 2017
Primary completion23 Jul 2020
Study completion24 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 652 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03159195
Sponsor's protocol ID: A5481090
Other IDs: IRIS
Acronym: IRIS
Status last verified: Jun 2025
First submitted: 17 May 2017
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

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.
PubMed 35567914
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.
PubMed 33498797
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.
PubMed 31050919

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Neoplasm of Breast trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
ClinicalTrials.gov ID: NCT03159195
Acronym / sponsor ID: IRIS / A5481090
Conditions: Malignant Neoplasm of Breast
Keywords: metastatic breast cancer, advanced breast cancer, HR+/ HER2-
Study type: Observational
Recruitment status: Completed
Enrolment: 652 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Jun 2017 (actual)
Primary completion: 23 Jul 2020 (actual)
Study completion: 24 Jun 2021 (actual)
First posted: 18 May 2017 (actual)
Results: Posted 17 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Breast Cancer Patients	–	–HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication.

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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 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 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.

Results and safety

Results posted to the registry on 17 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palbociclib + Aromatase Inhibitor (AI) (P+AI)	360	360
Palbociclib + Fulvestrant (P+FV)	292	292

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Palbociclib + Aromatase Inhibitor (P+AI) n = 360	Palbociclib + Fulvestrant (P+FV) n = 292
Value	84.1	79.8

Population analysed: FAS population included participants aged \>=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Palbociclib + Aromatase Inhibitor (P+AI) n = 360
Value	64.3

Population analysed: FAS population was analyzed for this outcome measure. Data for this outcome measure for reporting group ''P+FV'' was not collected due to limited time on treatment for participants in this group, data was not available beyond Month 12.

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Palbociclib + Aromatase Inhibitor (P+AI) n = 360	Palbociclib + Fulvestrant (P+FV) n = 292
Value	79.5	74.0

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Palbociclib + Aromatase Inhibitor (P+AI) n = 354	Palbociclib + Fulvestrant (P+FV) n = 290
Value	95.1	87.9

Population analysed: FAS:participants aged \>=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received P + letrozole/AI or P + FV in line with licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since P with FV initiation, or minimum of 6 months of follow up data since P with letrozole/AI initiation. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure.

Adverse events

Time frame: Not applicable as safety data was not planned to be collected for the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib + Aromatase Inhibitor (P+AI)	0 of 0	0 of 0	0
Palbociclib + Fulvestrant (P+FV)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35567914Mycock 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.
Derived from this study: PubMed 33498797Mycock 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.
Derived from this study: PubMed 31050919Waller 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Neoplasm of Breast, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03159195, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.