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

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 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)

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.

Time frame: 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.

Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020.

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.

Time frame: 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.

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.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020.

Number of participants according to number of metastases (0,1,2,greater than \[\>\] 2) is presented in this outcome measure.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020.

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.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

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.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020.

Number of participants who underwent surgery were described.

Time frame: At Baseline (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 as first or second line treatment between 01 January 2017 and 31 December 2020.

Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure.

Time frame: At Baseline (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 as first or second line treatment 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.

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)

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.

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)

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 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 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)

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.

Time frame: 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.