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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06307457
• Other study ID #: A5481188
• Status: Completed
• Start date: March 11, 2024
• Est. completion date: April 19, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results.	01 Jan 2017 - 31 Dec 2023
Primary	Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment	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	Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment		01 Jan 2017 - 31 Dec 2023
Secondary	PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results.	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results.	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results.	01 Jan 2017 - 31 Dec 2023
Secondary	OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment	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	OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment	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	OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment	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	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	Patients with a CCI score of 0 defines patients with no comorbidity besides the breast cancer disease	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1	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
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2	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
Secondary	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+)	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0	Patients with a CCI score of 0 defines patients with no comorbidity besides the breast cancer disease	01 Jan 2017 - 31 Dec 2023
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2	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
Secondary	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+)	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
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity	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
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity	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
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities	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
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results. Comorbidity: Cardiac disease	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results. Comorbidity: Vascular disease	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results. Comorbidity: Metabolic disease	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results. Comorbidity: Psychiatric disease	01 Jan 2017 - 31 Dec 2023
Secondary	PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system	PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first.; Patients will be censored for PFS by 31 December 2023; Progression of disease is based on scans and blood testing results. Comorbidity: Blood and lymphatic system	01 Jan 2017 - 31 Dec 2023
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease	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
Secondary	OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system	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

External Links

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