Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US Community Oncology Setting

By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 317

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting

Description

Inclusion Criteria:

1. Documented diagnosis of HR+/HER2- mBC
2. Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
3. Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes

Exclusion Criteria:

1. Enrollment in an interventional clinical trial during the study period
2. Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
3. Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PAL + FUL; Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Chemotherapy	Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.	From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Number of Participants According to Reasons for Treatment Discontinuation	The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.	From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Duration of Treatment (rwDOT)	Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.	From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to Next Treatment (TTNT) From Index Treatment	Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.	From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of Participants With Provider Documented Disease Progression	Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.	From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Time to Tumor Progression (rwTTP)	The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.	From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Progression-Free Survival (rwPFS)	The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.	From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Overall Survival (OS)	Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.	From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to chemotherapy	Treatment initiation through end of study (Assessed up to 60 months)
Reasons for treatment discontinuation	Treatment initiation through end of study (Assessed up to 60 months)
Real-world duration of therapy (rwDOT)	Treatment initiation through end of study (Assessed up to 60 months)
Time to next treatment (TTNT)	Treatment initiation through end of study (Assessed up to 60 months)
Provider-documented progression	Treatment initiation through end of study (Assessed up to 60 months)
Real-world time to progression (rwTTP)	Treatment initiation through end of study (Assessed up to 60 months)
Real-world progression-free survival (rwPFS)	Treatment initiation through end of study (Assessed up to 60 months)
Overall survival (OS)	Treatment initiation through end of study (Assessed up to 60 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment	The percentage of participants classified according to the dosing strength of Palbociclib and Fulvestrant as their index treatment were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period.	At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study)
Duration of Treatment for Advanced Metastatic Breast Cancer	The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure.	From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer	Percentage of participants with prior adjuvant hormonal treatment for breast cancer were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period.	Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study)
Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer	Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure.	Quarter(Q)1 2015,Q2 2015,Q3 2015,Q4 2015,Q1 2016,Q2 2016,Q3 2016,Q4 2016,Q1 2017,Q2 2017,Q3 2017,Q4 2017,Q1 2018,Q2 2018,Q3 2018,Q4 2018,Q1 2019,Q2 2019,Q3 2019,Q4 2019(data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of Participants With Change in Dose	The percentage of participants with dose change for index treatment were reported in this outcome measure.	From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2019
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: A5481128; US oncology (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.