Clinical trial NCT05452798: A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
Official title: A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer
HR+/ HER2-
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 1054
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: Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib (1st or 2nd line between 01 Jan 2017- 31 Dec 2020).

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


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
timeFrame: 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)
measure: Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
timeFrame: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)
Secondary outcomes:
measure: Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI
timeFrame: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
measure: Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant
timeFrame: 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)
measure: Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant
timeFrame: From start date of study treatment until stop date of treatment (maximum up to 5.2 years)
measure: OS in Participants Who Received Palbociclib in Combination With Fulvestrant
timeFrame: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
measure: Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression
timeFrame: At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants According to Type of Metastases
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants According to Number of Metastases
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants According to Location of Metastases
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants Who Underwent Surgery
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants According to Type of Adjuvant Treatment
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Number of Participants With De Novo and Recurrent Metastatic Breast Cancer
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
measure: Median Time From Initial Breast Cancer Diagnosis to Relapse
timeFrame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Breast Cancer Group
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: