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Completed

NCT Number: 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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Breast Cancer Group

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)

    Time frame: 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.

  2. Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)

    Time frame: 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 outcomes

  1. Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI

    Time frame: 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.

  2. Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant

    Time frame: 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.

  3. Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant

    Time frame: 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.

  4. OS in Participants Who Received Palbociclib in Combination With Fulvestrant

    Time frame: 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.

  5. Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression

    Time frame: 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.

  6. Number of Participants According to Type of Metastases

    Time frame: 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.

  7. Number of Participants According to Number of Metastases

    Time frame: 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.

  8. Number of Participants According to Location of Metastases

    Time frame: 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.

  9. Number of Participants Who Underwent Surgery

    Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])

    Number of participants who underwent surgery were described.

  10. Number of Participants According to Type of Adjuvant Treatment

    Time frame: 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.

  11. Number of Participants With De Novo and Recurrent Metastatic Breast Cancer

    Time frame: 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.

  12. Median Time From Initial Breast Cancer Diagnosis to Relapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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