NCT07178743Completed
Emulation of the PALOMA-2 Trial
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6097 (actual)
- First submitted
- 8 Sept 2025
- Start date
- 14 Jul 2025
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07178743
What you commit to
- Study type: Observational
- Participants enrolled: 6097
- From 14 Jul 2025 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with CDK4/6 inhibitor
- Systemic anticancer therapy other than palbocicilib or letrozole
- Treatment with non-steroidal aromatase inhibitor (i.e.anastrozole, letrozole)
Other illness
- Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
Other
- HER2+
- CNS metastases
Who the study is looking for
- 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
Criteria the registry did not label
- Study Period:
- ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024
- ENCORE database 3 (EDB3): Follow-up information through June 2023 (there is no specific time period restrictions for patient eligibility)
- ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.