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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460911
• Other study ID #: A5481128
• Secondary ID: US oncology
• Status: Completed
• Start date: October 19, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Pfizer United States	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 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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

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