- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06307457
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Copenhagen University Hospital, Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Palbociclib in combination with AI
Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI, in Denmark.
|
Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI as first-line treatment, in Denmark.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. |
01 Jan 2017 - 31 Dec 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
01 Jan 2017 - 31 Dec 2023
|
|
PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. |
01 Jan 2017 - 31 Dec 2023
|
OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. |
01 Jan 2017 - 31 Dec 2023
|
OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. |
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into Charlson Comorbidity Index (CCI) point score of 0
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 0 defines patients with no comorbidity besides the breast cancer disease
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 1 defines patients with one comorbidity of the type with a score of 1, e.g., myocardial infarction or diabetes mellitus.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 2 defines patients with two comorbidities each having a score of 1 or one comorbidity alone with a CCI score of 2, e.g., diabetes mellitus with organ damage or a solid tumor besides breast cancer disease.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+)
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 3 or higher (3+) defines patients with severe comorbidity/ies having one comorbidity with a CCI score of 6, e.g., HIV/AIDS, or two or more comorbidities each with CCI scores of 1-2.
These comorbidities are also besides the patients' breast cancer disease.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 0 defines patients with no comorbidity besides the breast cancer disease
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 1 defines patients with one comorbidity of the type with a score of 1, e.g., myocardial infarction or diabetes mellitus.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 2 defines patients with two comorbidities each having a score of 1 or one comorbidity alone with a CCI score of 2, e.g., diabetes mellitus with organ damage or a solid tumor besides breast cancer disease.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+)
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Patients with a CCI score of 3 or higher (3+) defines patients with severe comorbidity/ies having one comorbidity with a CCI score of 6, e.g., HIV/AIDS, or two or more comorbidities each with CCI scores of 1-2.
These comorbidities are also besides the patients' breast cancer disease.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
No comorbidity from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
One comorbidity from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Two or more comorbidities from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
No comorbidity from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
One comorbidity from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
Two or more comorbidities from the five main disease groups: Cardiac disease, Vascular disease, Metabolic disease, Psychiatric disease, Blood and lymphatic system.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.
|
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. Comorbidity: Cardiac disease |
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. Comorbidity: Vascular disease |
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. Comorbidity: Metabolic disease |
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. Comorbidity: Psychiatric disease |
01 Jan 2017 - 31 Dec 2023
|
OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system
Time Frame: 01 Jan 2017 - 31 Dec 2023
|
OS is defined as the date of relapse or stage IV disease (index date) until death of any cause. - Patients will be censored for OS by 31 December 2023. Comorbidity: Blood and lymphatic system |
01 Jan 2017 - 31 Dec 2023
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Advanced Breast Cancer
- Age
- Palbociclib
- Charlson Comorbidity Index (CCI)
- Denmark
- First-line Treatment
- Comorbidities
- HR+/HER2-
- Metastatic Breast Cancer (mBC)
- ICD10: C50
- Hormone receptor positive / Human Epidermal growth factor Receptor 2 negative
- Endocrine sensitive
- Endocrine resistant
- de novo mBC
- Danish Breast Cancer Group (DBCG)
- Aromatase Inhibitor (AI)
- Real-World Evidence (RWE)
- Non-Interventional Study (NIS)
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5481188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Palbociclib in combination with AI
-
Arvinas Estrogen Receptor, Inc.PfizerActive, not recruiting
-
Yuehui YinUnknownAtrial Fibrillation | ArrythmiaChina
-
Shen LinUnknownColorectal Cancer | Esophageal Squamous Cell Carcinoma | Biliary Tract Cancer | Targeted Therapy | HER2China
-
Peking Union Medical CollegeNot yet recruiting
-
Aurora Health CareRecruiting
-
Hunan Province Tumor HospitalNot yet recruitingNon-small Cell Lung CancerChina
-
Hunan Province Tumor HospitalNot yet recruitingNon-Small Cell Lung CancerChina
-
AkesoNot yet recruiting
-
Sun Yat-sen UniversityRecruitingPeripheral T-cell LymphomaChina
-
Second Affiliated Hospital of Nanchang UniversityRecruitingImmunotherapy | Tislelizumab | Pulmonary Pleomorphic CarcinomaChina