Clinical trial NCT05361655: Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
Official title: Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: cyclin-dependent kinase 4/6i (CDK4/6i)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 2888
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: HR+/HER2- MBC adult patients treated with Palbociclib + AI or AI alone between February2015 and September, 2020

Brief summary: A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.


Eligibility criteria: Inclusion Criteria:

* Confirmed HR+/HER2- status after MBC diagnosis.
* Received palbociclib + AI or AI as first-line therapy

Exclusion Criteria:

* Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC
* First structured activity greater than 90 days after MBC diagnostic date
* Treatment with a CDK4/6 inhibitor as part of a clinical trial

Primary outcomes:
measure: Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer
timeFrame: From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months)
Secondary outcomes:
measure: Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer
timeFrame: From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months)
measure: Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer
timeFrame: From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months)
measure: Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer
timeFrame: From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months)
measure: Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only
timeFrame: At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months)
measure: Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only
timeFrame: At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months)
measure: Duration of Treatment
timeFrame: From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months)
measure: Time to Next Line of Treatment
timeFrame: From start of study treatment to start of next line of therapy (up to 68 months)
measure: Time to Subsequent Chemotherapy
timeFrame: From start of study treatment to administration of different chemotherapeutic agent (up to 68 months)
measure: Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer
timeFrame: From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: 10017
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer. 2022 Oct 11;8(1):114. doi: 10.1038/s41523-022-00479-x.