Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Metastatic Breast Cancer Clinical Trial

Official title:

Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176354
• Other study ID #: A5481122
• Status: Active, not recruiting
• Start date: January 25, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

Description:

Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female sex

2. At least 18 years old at MBC diagnosis

3. Diagnosis of MBC at any point in patient history

1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC

2. Confirmation of metastatic disease

3. At least 2 document clinical visits

4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents

4. HR+/HER2-

1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis

2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis

5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion Criteria:

1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC

2. First structured activity greater than 90 days after MBC diagnostic date

3. Treatment with a CDK4/6 inhibitor as part of a clinical trial

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
• Palbociclib + Letrozole
Palbociclib + Letrozole therapy
• Letrozole
Letrozole monotherapy

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world progression free survival (rwPFS)	Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months
Secondary	Overall survival	Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.	From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 52 months
Secondary	Real-world tumor response (rwTR)	Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment	From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months
Secondary	Time to next line of therapy	Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months	From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Secondary	Time to first use of chemotherapy	Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months	From date of index treatemnt to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

External Links

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