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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
Secondary outcomes:
measure: Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: 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
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: 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+)
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: 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+)
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease
timeFrame: 01 Jan 2017 - 31 Dec 2023
measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system
timeFrame: 01 Jan 2017 - 31 Dec 2023
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: