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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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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