A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
- Registration Number
- NCT06307457
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 604
- 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
- There are no exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Palbociclib in combination with AI Palbociclib in combination with AI Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib in combination with AI, in Denmark.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 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 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.
Overall Survival (OS) 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 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.
- Secondary Outcome Measures
Name Time Method 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) 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 mm. Kaplan-Meier method was used for analysis. PFS per age category (\< 65 years, 65-75 years and \> 75 years) were reported in this outcome measure. 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.
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) 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. OS per age category such as \< 65 years, 65-75 years and \>75 years were reported in this outcome measure. 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.
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) PFS was defined as the time from the index date to progression or death, whichever occurred first. CCI was used as data source for comorbidity. Each comorbidity recorded for participant, had score between 0 to 6 as per comorbidity burden, if it was part of CCI. Higher score=more severe comorbidity status. CCI score 0:participants with no comorbidity besides BC disease, CCI score 1:participant with one comorbidity with score of 1,e.g.,myocardial infarction or diabetes mellitus(DM), CCI score 2:participant with two comorbidities each classified with score of 1 or one single comorbidity classified with score of 2,e.g.,DM with organ damage, CCI score of 3or higher: participant with severe comorbidity, i.e. those having one comorbidity classified with score of 6(e.g., Human Immunodeficiency Virus/Acquired Immuno Deficiency Syndrome),or two or more comorbidities each classified with scores of1-2,all in addition to participant's BC disease. Index date=date of relapse or stage IV disease.
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) OS: time from date of relapse or stage IV disease to death at any cause. CCI was used as data source for comorbidity in study. For each comorbidity recorded for participant score between 0 to 6 was assigned based on comorbidity burden, whether it was part of CCI.Higher score=more severe comorbidity status.CCI scores: CCI score 0:participants with no comorbidity besides BC disease, CCI score 1:participant with one comorbidity with score of 1,e.g., myocardial infarction or DM,CCI score 2:participant with two comorbidities each classified with score of 1 or one single comorbidity classified with score of 2,e.g.,DM with organ damage, CCI score of 3 or higher: participant with severe comorbidity,i.e.those having one comorbidity classified with score of 6(e.g., Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome),or two or more comorbidities each classified with scores of 1-2,all in addition to participant's BC disease. Index date=date of relapse or stage IV disease.
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) PFS was defined as the time from the index date to progression or death, whichever occurred first. Participants were censored for PFS by 1 February 2024. Progression was based on radiological, clinical, and biochemical examination from the treating departments. Participants were split into three comorbidity groups - no comorbidity (0), one comorbidity and two or more comorbidities. Comorbidities included myocardial infarction, congestive heart failure (CHF), peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, ulcer disease, mild liver disease, DM, hemiplegia, moderate-severe renal disease, DM with end organ damage, any tumor, leukemia, lymphoma, moderate-severe liver disease, metastatic solid tumor and acquired immune deficiency syndrome/human immune virus (AIDS/HIV). Index date was the date of relapse or stage IV disease.
OS 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) OS was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. Participants were split into three comorbidity groups - no comorbidity (0), one comorbidity and two or more comorbidities. Comorbidities included myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, ulcer disease, mild liver disease, DM, hemiplegia, moderate-severe renal disease, DM with end organ damage, any tumor, leukemia, lymphoma, moderate-severe liver disease, metastatic solid tumor and AIDS/HIV. Index date was the date of relapse or stage IV disease.
PFS Per Type of Comorbidity 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 was defined as the time from the index date to progression or death, whichever occurred first. Participants were censored for PFS by 1 February 2024. Progression was based on radiological, clinical, and biochemical examination from the treating departments. Comorbidities were categorized into five main disease groups: cardiac disease, vascular disease, metabolic disease, psychiatric disease and blood and lymphatic system. Results for cardiac disease, vascular disease and metabolic disease have been reported in this outcome measure. 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.
OS Per Type of Comorbidity 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 was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. Comorbidities were categorized into five main disease groups: Cardiac disease, vascular disease, metabolic disease, psychiatric disease and blood and lymphatic system. Results for cardiac disease, vascular disease and metabolic disease have been reported in this outcome measure. Index date was the date of relapse or stage IV disease.
PFS Per Visceral Disease Status 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 was defined as the time from the index date to progression or death, whichever occurred first. Participants were censored for PFS by 1 February 2024. Progression was based on radiological, clinical, and biochemical examination from the treating departments. Visceral disease status was defined as metastases in the visceral organs, e.g., lung, liver. Non-visceral disease status was defined as metastases in the non-visceral organs, e.g., bone, skin, lymph nodes. PFS in participants with visceral and non-visceral disease status is reported in this outcome measure. 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.
OS Per Visceral Disease Status 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 was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. Visceral disease status was defined as metastases in the organs, e.g., lung, liver. Non-visceral disease status was defined as metastases in the non-visceral organs, e.g., bone, skin, lymph nodes. OS per visceral disease status was reported as visceral and non-visceral disease status in this outcome measure. Index date was the date of relapse or stage IV disease.
PFS Per Bone Disease Status 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 was defined as the time from the index date to progression or death, whichever occurred first. Participants were censored for PFS by 1 February 2024. Progression was based on radiological, clinical, and biochemical examination from the treating departments. PFS was reported in participants with bone only (metastasis within bones) and non-bone only (metastasis within organs excluding bones) disease status in this outcome measure. 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.
OS Per Bone Disease Status 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 was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. OS was reported in participants with bone only (metastasis within bones) and non-bone only (metastasis within organs excluding bones) disease status in this outcome measure. Index date was the date of relapse or stage IV disease.
PFS Per Endocrine Status 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 was defined as the time from the index date to progression or death, whichever occurred first. Participants were censored for PFS by 1 February 2024. Progression was based on radiological, clinical, and biochemical examination from the treating departments. Endocrine resistant participants were defined as recurrent participants with advanced disease within 12 months of completing adjuvant endocrine therapy or during adjuvant endocrine therapy. Endocrine sensitive participants were defined as recurrent participants with advanced disease after 12 months of completing adjuvant endocrine therapy, recurrent participants who received no adjuvant endocrine therapy or participants with de novo, advanced breast cancer. De novo participants were defined as newly metastatic participants. Index date was the date of relapse or stage IV disease.
OS Per Endocrine Status 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 was defined as the time from date of relapse or stage IV disease (index date) to death at any cause. OS per endocrine status was reported in participants with endocrine resistant, endocrine sensitive and de novo metastatic status in this outcome measure. Endocrine resistant participants were defined as recurrent participants with advanced disease within 12 months of completing adjuvant endocrine therapy or during adjuvant endocrine therapy. Endocrine sensitive participants were defined as recurrent participants with advanced disease after 12 months of completing adjuvant endocrine therapy, recurrent participants who received no adjuvant endocrine therapy or participants with de novo, advanced breast cancer. De novo participants were defined as newly metastatic participants. Index date was the date of relapse or stage IV disease.
Trial Locations
- Locations (1)
Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, Denmark
Copenhagen University Hospital, Rigshospitalet🇩🇰Copenhagen, Denmark