CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

Registration Number
NCT06607601
Lead Sponsor
Aetion, Inc.
Brief Summary

The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. The main questions this study aims to answer a...

Detailed Description

The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCT) as a benchmark for causal effect estimates, a series of RCT emulations ...

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
724
Inclusion Criteria
  • Breast cancer diagnosis
  • Histology not indicative of non-adenocarcinoma histologies
  • Metastatic disease
  • Estrogen-receptor positive (ER+)
  • No prior systemic treatment for metastatic breast cancer
  • Post-menopausal
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or missing or Karnofsky performance status >=50 or missing
  • No lab results indicating inadequate organ function, as defined in the PALOMA-2 RCT protocol
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Exclusion Criteria
  • Human epidermal growth factor receptor 2 (HER2) positive tumor
  • Diagnosis of brain, central nervous system, and/or spinal cord metastases
  • Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
  • Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
  • Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
  • Anti-cancer therapy or major cancer-related surgery within 2 weeks before study treatment initiation
  • Diagnosis of a second primary malignancy within 3 years prior to study treatment initiation
  • Diagnosis of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
  • Diagnosis of hypocalcemia, hypokalemia, or hypomagnesemia
  • Diagnosis of myocardial infarction, angina, ongoing cardiac dysrhythmias, atrial fibrillation, congestive heart failure, cerebral infarction, transient ischemic attack, or pulmonary embolism in the 6 months prior to study treatment initiation
  • Diagnosis of inflammatory bowel disease chronic diarrhea, or short bowel syndrome
  • Diagnosis of human immunodeficiency virus infection
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ExposedPalbociclibPatients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer
ExposedLetrozolePatients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer
ComparatorLetrozolePatients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer
Primary Outcome Measures
NameTimeMethod
Real-world progression-free survival (rwPFS)From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.

Time from study treatment initiation to disease progression or death

Secondary Outcome Measures
NameTimeMethod
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