Emulation of the PALOMA-2 Trial

Completed

Conditions studied: Advanced Breast Cancer

In brief

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Key facts

Study ID

NCT07178743

Run by

Brigham and Women's Hospital

People needed

6097

Starts

2025-07-14

Expected to finish

2026-03-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer who receive treatment without curative intent
• The line of therapy for patients in EDB1 and EDB3 is implicitly advanced/metastatic because the line of therapy classification starts after their advanced/metastatic diagnosis in the respective database
• In EDB4, patients must explicitly have any evidence of a metastasis prior initiating palbociclib plus letrozole or letrozole alone
• Adenocarcinoma histology
• No prior systemic treatment for advanced/metastatic disease
• ECOG performance status of 0 or 1

You may not qualify if…

• HER2+
• CNS metastases
• Prior treatment with CDK4/6 inhibitor
• Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
• Systemic anticancer therapy other than palbocicilib or letrozole
• Treatment with non-steroidal aromatase inhibitor (i.e.anastrozole, letrozole)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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