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

NCT05452798 | Completed Results

• 1 other identifier: A5481176
• Study Type: observational
• Target: 1,054
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer; HR+/ HER2-

Outcome Measures

Primary Outcomes (2)

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

  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.

  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)

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

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

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

Secondary Outcomes (12)

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

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

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

  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)

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

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

• OS in Participants Who Received Palbociclib in Combination With Fulvestrant

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Danish Breast Cancer Group

Copenhagen, Denmark

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)