N/A Completed N=242

Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy

Breast Cancer

Source: ClinicalTrials.gov NCT04394247 ↗

Enrolled (actual)

242

Serious AEs

—

Results posted

Mar 2023

Primary outcomePrimary: Percentage of Participants With Treatment Regimen Distribution — 100; 39.67 Percentage of participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Treatment Regimen Distribution	100; 39.67	—
PRIMARY Percentage of Participants With Sequence of Treatment Lines	100; 21.49; 12.81; 2.07; 3.31	—
PRIMARY Percentage of Participants With Their Starting Dose and End Dose	89.7; 7.4; 1.2; 1.7; 60.7; 27.7	—
PRIMARY Percentage of Participants With Type of Dose Adjustment	0.4; 31.0; 66.9; 1.7	—
PRIMARY Percentage of Participants With Their Reason For Treatment Discontinuation	26.4; 14.9; 2.5; 2.5; 0; 2.1	—
PRIMARY Time to Dose Adjustment	55.0	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 3	0.95	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 6	0.84	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 12	0.75	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 18	0.66	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 24	0.59	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 30	0.53	—
PRIMARY Probability of Real-World Progression-Free Survival (rwPFS) at Month 36	0.48	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 3	0.99	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 6	0.97	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 12	0.9	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 18	0.84	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 24	0.78	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 30	0.73	—
PRIMARY Probability of Real-World Overall Survival (rwOS) at Month 36	0.69	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3	0.93	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6	0.84	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12	0.67	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18	0.56	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24	0.49	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30	0.41	—
PRIMARY Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36	0.36	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3	0.97	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6	0.89	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12	0.73	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18	0.62	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24	0.55	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30	0.47	—
PRIMARY Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36	0.41	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 3	0.98	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 6	0.93	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 12	0.83	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 18	0.74	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 24	0.69	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 30	0.63	—
PRIMARY Probability of Participants Without Subsequent Chemotherapy or Death at Month 36	0.58	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3	0.82	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6	0.76	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12	0.73	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18	0.69	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24	0.68	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30	0.67	—
PRIMARY Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36	0.65	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04394247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.