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

NCT06607601 | Completed FDA Drug

• 1 other identifier: DS3-PALOMA2
• Study Type: observational
• Target: 724
• Locations: 0 countries
• Sites: N/A

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 are:

1. 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. 2.How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?

Conditions

Metastatic Breast Cancer

Keywords

real-world evidence; real-world data; oncology; pharmacoepidemiology; comparative effectiveness research; trial emulation

Outcome Measures

Primary Outcomes (1)

• Real-world progression-free survival (rwPFS)

  Time from study treatment initiation to disease progression or death

  From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 33 months.

Study Arms (2)

Exposed

Patients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer

Drug: Palbociclib; Drug: Letrozole

Comparator

Patients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer

Drug: Letrozole

Interventions

Palbociclib DRUG

Treatment information in the electronic health record indicates initiation of palbociclib after metastatic diagnosis

Exposed

Letrozole DRUG

Treatment information in the electronic health record indicates initiation of letrozole after metastatic diagnosis

Comparator; Exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients identified in the electronic health record data source with metastatic ER+/HER2- breast cancer initiating treatment with the study drugs (palbociclib, letrozole)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aetion, Inc.: lead
• AbbVie: collaborator
• Amgen: collaborator
• AstraZeneca: collaborator
• Bayer: collaborator
• Gilead Sciences: collaborator
• Janssen, LP: collaborator
• Pfizer: collaborator

Related Publications (1)

• Finn 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

palbociclib; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: February 1, 2010
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share