Clinical trial · Observational
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
Impact of Age and Comorbidities on Treatment Outcomes of First-line Treatment With Palbociclib in Combination With an Aromatase Inhibitor (AI) in Patients Diagnosed With HR+/HER2 - Metastatic Breast Cancer - Danish Non-Interventional Study
- 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 purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who: * have advanced or metastatic breast cancer that is spread to other parts of the body. * have HR+/HER2- (hormone receptor positive\* / human epidermal growth factor receptor 2 negative\*\*) breast cancer types. * Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment. * Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment. * have started treatment in the period between January 2017 and December 2021. The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib in combination with AI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Palbociclib in combination with AI
- description
- Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI, in Denmark.
- interventionNames
- Drug: Palbociclib in combination with AI
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From index date to disease progression or death or censoring date, whichever occurred first (data collected from 1 January 2017 to 1 February 2024 [maximum up to 7.09 years] and observed retrospectively for approximately 1.3 months of this study)
- description
- PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with breast cancer (ICD-10: C50) * A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer * Endocrine sensitive, endocrine resistant, or de novo mBC patient * Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI Exclusion Criteria: * There are no exclusion criteria for this study
References
Publications (1)
- DERIVEDAlan Celik, Dahl LS, Garly R, Glavicic V, Sharma MB, Yammeni S, Khan H, Hauberg DS, Kapel HS, Knoop A, Berg T. Impact of age and comorbidities on real-world outcomes in advanced breast cancer patients treated with palbociclib in first line: a nation-wide Danish retrospective study. Acta Oncol. 2025 Jun 11;64:778-783. doi: 10.2340/1651-226X.2025.43226. PMID 40500959