Clinical trial NCT05155566: Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
Official title: Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Metastatic
Keywords: human epidermal growth factor receptor 2 negative (HER2-)
hormone receptor positive (HR+)
advanced breast cancer (ABC)
metastatic breast cancer (MBC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 847
Sex: FEMALE
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: Retrospective medical data review of patients who have received palbociclib combination treatments as first line treatment regardless of combination partner and labelled use in Argentina, Chile, Peru, Mexico and a combined sample in Costa Rica and Panama.

Brief summary: To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.


Eligibility criteria: Physician inclusion criteria:

* Oncologist or gynecologist.
* Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.

Patient inclusion criteria:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib as a first line therapy.
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of six months of follow up data since palbociclib initiation.

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 as first line therapy.

Primary outcomes:
measure: Progression Free Rate at Month 6
timeFrame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
measure: Progression Free Rate at Month 12
timeFrame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
measure: Progression Free Rate at Month 18
timeFrame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
measure: Progression Free Rate at Month 24
timeFrame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
measure: Objective Response Rate
timeFrame: From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation
timeFrame: 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
measure: Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation
timeFrame: 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
measure: Clinical Benefit Rate
timeFrame: From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib
timeFrame: From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Survival Rate at Month 6
timeFrame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
measure: Survival Rate at Month 12
timeFrame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
measure: Survival Rate at Month 18
timeFrame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
measure: Survival Rate at Month 24
timeFrame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
measure: Time From Palbociclib Initiation to Initial Response Recorded
timeFrame: From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Time From Palbociclib Initiation to Complete Response
timeFrame: From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Time From Palbociclib Initiation to Partial Response
timeFrame: From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Follow-up Time Since Palbociclib Initiation
timeFrame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Number of Participants With Supportive Therapies
timeFrame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Duration of Ongoing Palbociclib Treatment
timeFrame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Duration of Discontinued Palbociclib Treatment
timeFrame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Number of Participants According to Therapies Received Post Palbociclib Treatment
timeFrame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Time From Palbociclib Initiation to First Dose Reduction
timeFrame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Duration of Dose Interruption
timeFrame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
measure: Duration of Cycle Delays
timeFrame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer country office
city: Bollington
country: United Kingdom
facility: Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK
state: Chesshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: