N/A
N=604
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06307457 ↗Enrolled (actual)
604
Serious AEs
—
Results posted
Jun 2025
Primary outcome: Primary: Progression-Free Survival (PFS) — 30.6 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Palbociclib in combination with AI (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
30.6 | — |
| PRIMARY Overall Survival (OS) |
55.6 | — |
| SECONDARY PFS Based on Age of Participants |
25.8; 35.7; 29.8 | 0.031 sig |
| SECONDARY OS Based on Age of Participants |
52.6; 60.8; 50.1 | 0.012 sig |
| SECONDARY PFS Per Charlson Comorbidity Index (CCI) Score |
32.8; 32.0; 29.7; 21.5 | 0.061 |
| SECONDARY OS Per CCI Score |
57.6; 50.1; 53.1; 45.2 | 0.080 |
| SECONDARY PFS Per Number of Comorbidities |
32.8; 27.9; 23.6 | 0.2 |
| SECONDARY OS Per Number of Comorbidities |
57.6; 50.1; 52.7 | 0.093 |
| SECONDARY PFS Per Type of Comorbidity |
27.9; 32.3; 25.5 | >0.9 |
| SECONDARY OS Per Type of Comorbidity |
61.2; 47.4; 50.1 | 0.7 |
| SECONDARY PFS Per Visceral Disease Status |
34.6; 24.2 | 0.005 sig |
| SECONDARY OS Per Visceral Disease Status |
59.2; 50.6 | 0.005 sig |
| SECONDARY PFS Per Bone Disease Status |
34.6; 29.0 | 0.14 |
| SECONDARY OS Per Bone Disease Status |
58.3; 54.2 | 0.2 |
| SECONDARY PFS Per Endocrine Status |
21.7; 31.8; 32.0 | 0.047 sig |
| SECONDARY OS Per Endocrine Status |
43.5; 56.6; 58.9 | 0.041 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06307457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.