Clinical trial · Observational
CARE Initiative: Real-world Emulation of the PALOMA-2 Trial
CARE Initiative Study: Real-world Emulation of the PALOMA-2 Comparative Effectiveness Trial of Palbociclib and Letrozole vs. Placebo and Letrozole for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 are: 1. Do patients with metastatic ER+/HER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival (rwPFS) compared with patients treated with letrozole alone? 2. How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Exposed
- description
- Patients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer
- interventionNames
- Drug: Palbociclib
- Drug: Letrozole
- label
- Comparator
- description
- Patients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- Real-world progression-free survival (rwPFS)
- timeFrame
- From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (1)
- BACKGROUNDFinn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303. PMID 27959613