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

Completed Results posted Last updated 1 March 2024

What this trial tests

trial in Breast Cancer in 1,054 participants. Completed in 1 August 2022.

Timeline

1 February 2022

Primary endpoint
1 August 2022

1 August 2022

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,054
Start date	1 February 2022
Primary completion	1 August 2022
Estimated completion	1 August 2022
Sites	1 location across Denmark

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) Primary · 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 cance

Group	Value	95% CI
Palbociclib	27.4	12.4 – 57.3

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

Group	Value	95% CI
Palbociclib	54.2	29.5 – 72.3

Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant Secondary · 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 t

Group	Value	95% CI
Palbociclib	14.9	5.9 – 30.3

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

Group	Value	95% CI
Palbociclib	11.2	3.7 – 23.7

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

Group	Value	95% CI
Palbociclib	18.5	7 – 41.1

OS in Participants Who Received Palbociclib in Combination With Fulvestrant Secondary · 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.

Group	Value	95% CI
Palbociclib	32.9	19.0 – 56.0

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

Group	Value	95% CI
Palbociclib	350
Palbociclib	315
Palbociclib	2

Number of Participants According to Type of Metastases Secondary · 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.

Group	Value	95% CI
Palbociclib	105
Palbociclib	405
Palbociclib	530
Palbociclib	14

Number of Participants According to Number of Metastases Secondary · 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.

Group	Value	95% CI
Palbociclib	14
Palbociclib	375
Palbociclib	303
Palbociclib	362

Number of Participants According to Location of Metastases Secondary · 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.

Skin

Group	Value	95% CI
Palbociclib	80

Bone

Group	Value	95% CI
Palbociclib	790

Lung

Group	Value	95% CI
Palbociclib	417

Liver

Group	Value	95% CI
Palbociclib	268

Central nervous system (CNS)

Group	Value	95% CI
Palbociclib	41

Other

Group	Value	95% CI
Palbociclib	480

Number of Participants Who Underwent Surgery Secondary · At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])

Number of participants who underwent surgery were described.

Group	Value	95% CI
Palbociclib	96

Number of Participants According to Type of Adjuvant Treatment Secondary · 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.

Endocrine therapy

Group	Value	95% CI
Palbociclib	552

Taxane

Group	Value	95% CI
Palbociclib	202

Cyclophosphamide and epirubicin

Group	Value	95% CI
Palbociclib	194

Unknown

Group	Value	95% CI
Palbociclib	176

Other

Group	Value	95% CI
Palbociclib	122

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.