Clinical trial NCT04460911: Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Chemotherapy
timeFrame: 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)
measure: Number of Participants According to Reasons for Treatment Discontinuation
timeFrame: 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)
measure: Real-World Duration of Treatment (rwDOT)
timeFrame: 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)
measure: Time to Next Treatment (TTNT) From Index Treatment
timeFrame: 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)
measure: Percentage of Participants With Provider Documented Disease Progression
timeFrame: 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)
measure: Real-World Time to Tumor Progression (rwTTP)
timeFrame: 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)
measure: Real-World Progression-Free Survival (rwPFS)
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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 outcomes:
Other outcomes:
measure: Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment
timeFrame: At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study)
measure: Duration of Treatment for Advanced Metastatic Breast Cancer
timeFrame: 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)
measure: Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer
timeFrame: 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)
measure: Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer
timeFrame: 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)
measure: Percentage of Participants With Change in Dose
timeFrame: From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study)
Locations:
city: New York
country: United States
facility: Pfizer United States
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: