Trial Outcomes & Findings for A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark (NCT NCT05452798)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1054 participants

Primary outcome 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)

Results posted on

2024-03-01

Participant Flow

Participants diagnosed with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) locally advanced or metastatic breast cancer (BC) who initiated treatment with palbociclib in Denmark as either first or second line treatment between 01 January 2017 and 31 December 2020 were observed. Data was collected retrospectively from Danish Breast Cancer Group (DBCG) registry. Data analysis was performed over approximately 5 months in this study.

Participant milestones

Participant milestones
Measure	Palbociclib Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Overall Study STARTED	1054
Overall Study COMPLETED	1054
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palbociclib n=1054 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Age, Continuous Age	66.8 years STANDARD_DEVIATION 11.4 • n=1054 Participants
Sex: Female, Male Sex · Female	1054 Participants n=1054 Participants
Sex: Female, Male Sex · Male	0 Participants n=1054 Participants

PRIMARY outcome

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)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=525 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)	27.4 Months Interval 12.4 to 57.3

PRIMARY outcome

Timeframe: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020.

ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.

Outcome measures

Outcome measures
Measure	Palbociclib n=525 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)	18.5 Months Interval 7.0 to 41.1

SECONDARY outcome

Timeframe: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=525 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI	54.2 Months Interval 29.5 to 72.3

SECONDARY outcome

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)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=524 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant	14.9 Months Interval 5.9 to 30.3

SECONDARY outcome

Timeframe: From start date of study treatment until stop date of treatment (maximum up to 5.2 years)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020.

ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib.

Outcome measures

Outcome measures
Measure	Palbociclib n=524 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant	11.2 Months Interval 3.7 to 23.7

SECONDARY outcome

Timeframe: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with fulvestrant between 01 January 2017 and 31 December 2020.

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.

Outcome measures

Outcome measures
Measure	Palbociclib n=524 Participants Participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib as first or second line treatment between 01 January 2017 and 31 December 2020 were observed in this retrospective study.
OS in Participants Who Received Palbociclib in Combination With Fulvestrant	32.9 Months Interval 19.0 to 56.0

SECONDARY outcome

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

Population: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI or fulvestrant between 01 January 2017 and 31 December 2020. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.