A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark

Completed

Conditions: Breast Cancer

Registration Number: NCT05452798

Lead Sponsor: Pfizer

Brief Summary: The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1054

Inclusion Criteria

Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10]: ICD-10 code for patients with breast cancer [DC50])
A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer
Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020
Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant

Exclusion Criteria

There are no exclusion criteria for this study

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)	From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)	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.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)	From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)	ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Underwent Surgery	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Number of participants who underwent surgery were described.
Number of Participants According to Type of Adjuvant Treatment	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Participants who received adjuvant treatment (endocrine therapy, taxane, cyclophosphamide and epirubicin, unknown and other) were described in this outcome measure. One participant may have received more than one type of adjuvant treatment.
Number of Participants According to Type of Metastases	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Number of participants according to type of metastases (visceral, non-visceral, both visceral and non-visceral and inoperable locally-advanced breast cancer \[ILABC\]) is presented in this outcome measure.
Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression	At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	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. Number of participants as per first subsequent post-palbociclib therapy upon disease progression was described in this outcome measure.
Number of Participants According to Number of Metastases	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Number of participants according to number of metastases (0,1,2,greater than \[\>\] 2) is presented in this outcome measure.
Number of Participants With De Novo and Recurrent Metastatic Breast Cancer	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure.
Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI	From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)	OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body.
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant	From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)	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. 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.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant	From start date of study treatment until stop date of treatment (maximum up to 5.2 years)	ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
OS in Participants Who Received Palbociclib in Combination With Fulvestrant	From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)	OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body.
Number of Participants According to Location of Metastases	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Number of participants according to location of metastases (skin, bone, lung, liver, central nervous system \[CNS\], other) is presented in this outcome measure. One participant may have more than one location of metastases.
Median Time From Initial Breast Cancer Diagnosis to Relapse	At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])	Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure.