A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.

NCT06307457 | Completed Results

• 2 other identifiers: A5481188NCT06307457
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer (mBC); ICD10: C50; Advanced Breast Cancer; HR+/HER2-; Hormone receptor positive / Human Epidermal growth factor Receptor 2 negative; Endocrine sensitive; Endocrine resistant; de novo mBC; Denmark; Danish Breast Cancer Group (DBCG); Palbociclib; Aromatase Inhibitor (AI); Real-World Evidence (RWE); Non-Interventional Study (NIS); Age; Comorbidities; First-line Treatment; Charlson Comorbidity Index (CCI)

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  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.

  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)

• Overall Survival (OS)

  OS was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. Participants were censored for OS by 1 February 2024. Index date was the date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body.

  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)

Secondary Outcomes (14)

• PFS Based on Age of Participants

  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)

• OS Based on Age of Participants

  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)

• PFS Per Charlson Comorbidity Index (CCI) Score

  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)

• OS Per CCI Score

  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)

• PFS Per Number of Comorbidities

  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)

Study Arms (1)

Palbociclib in combination with AI

Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI, in Denmark.

Drug: Palbociclib in combination with AI

Interventions

Palbociclib in combination with AI DRUG

Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI as first-line treatment, in Denmark.

Also known as: Ibrance

Palbociclib in combination with AI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The full dataset consists of endocrine sensitive, endocrine resistant and de novo HR+/HER2- mBC patients treated with palbociclib as first-line treatment (01 January 2017- 31 December 2021). Patients will be censored for OS and PFS by 31 December 2023.

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Alan 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 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 6, 2024
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)