NCT04498481

Brief Summary

This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

August 3, 2020

Last Update Submit

February 25, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (8)

  • Proportion of patients receiving various cancer treatment regimens

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Proportion of patients receiving each therapy sequence across lines

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Treatment persistence

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Progression Free Survival (PFS)

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Overall Survival (OS)

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Tumor response rate

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Proportion of patients that experience dose adjustment

    A/MBC diagnosis through end of study (assessed up to 24 months)

  • Proportion of patients who discontinue therapy

    A/MBC diagnosis through end of study (assessed up to 24 months)

Study Arms (1)

Breast cancer patients

HR+/HER2- advanced/metastatic breast cancer patients in the USA.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after 2/3/2015.

You may qualify if:

  • Female.
  • Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
  • Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
  • Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
  • Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
  • Age greater than or equal to 18 years at A/MBC diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer United States

New York, New York, 10017, United States

Location

Related Publications (1)

  • Robert N, Chen C, Doan J, Venkatasetty D, Espirito JL, Aguilar KM. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15.

    PMID: 39810652DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 4, 2020

Study Start

March 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)