Clinical trial NCT04394247: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
Official title: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving Palbociclib + Aromatase Inhibitor (AI) Combination Therapy as First-Line Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated palbociclib combination therapy with AI as the first-line therapy on or after 03 February 2015 up to and including 31 July 2019.

Brief summary: The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line treatment in the US community oncology setting.


Eligibility criteria: Inclusion Criteria:

* Female or male sex.
* Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
* Age ≥18 years at A/MBC diagnosis.
* Initiated palbociclib in combination with an AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019. Note that the date of the start of the inclusion period reflects the month of palbociclib US FDA approval.
* Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
* Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

Exclusion Criteria:

* Enrollment in an interventional clinical trial for A/MBC during the study observation period.
* Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
* Evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.

Primary outcomes:
measure: Percentage of Participants With Treatment Regimen Distribution
timeFrame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
measure: Percentage of Participants With Sequence of Treatment Lines
timeFrame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
measure: Percentage of Participants With Their Starting Dose and End Dose
timeFrame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
measure: Percentage of Participants With Type of Dose Adjustment
timeFrame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
measure: Percentage of Participants With Their Reason For Treatment Discontinuation
timeFrame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
measure: Time to Dose Adjustment
timeFrame: From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Progression-Free Survival (rwPFS) at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Real-World Overall Survival (rwOS) at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without Subsequent Chemotherapy or Death at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3
timeFrame: 3 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6
timeFrame: 6 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12
timeFrame: 12 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18
timeFrame: 18 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24
timeFrame: 24 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30
timeFrame: 30 months after treatment initiation any time during 5 years of study period
measure: Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36
timeFrame: 36 months after treatment initiation any time during 5 years of study period
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Syapse
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Law JW, Mitra D, Kaplan HG, Alfred T, Brufsky AM, Emir B, McCracken H, Liu X, Broome RG, Zhang C, DiCristo C, Chen C. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Curr Oncol. 2022 Feb 12;29(2):1047-1061. doi: 10.3390/curroncol29020089.