NCT04394247 is a clinical trial in Breast Cancer, sponsored by Pfizer.

Who is sponsoring NCT04394247?

NCT04394247 is sponsored by Pfizer.

What condition does NCT04394247 study?

NCT04394247 studies Breast Cancer.

Is NCT04394247 still recruiting?

NCT04394247 is currently completed. Last updated 21 March 2023.

Are results published for NCT04394247?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-21 · How we verify

NCT04394247

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 21 March 2023

What this trial tests

trial in Breast Cancer in 242 participants. Completed in 31 December 2020.

Timeline

30 June 2020

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	242
Start date	30 June 2020
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

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.

Percentage of Participants With Treatment Regimen Distribution Primary · From start of treatment to end of follow-up, up to a maximum of approximately 5 years

Regimen medications were defined as systemic therapies included in line regimen based on synapse line of therapy algorithm. Treatment regimen distribution included: first-line regimen; palbociclib along with aromatase inhibitor and second-line regimen; CDK4/6 inhibitor plus endocrine and chemotherapy. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.

First-line regimen

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	100

Second-line regimen

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	39.67

Percentage of Participants With Sequence of Treatment Lines Primary · From start of treatment to end of follow-up, up to a maximum of approximately 5 years

Line of therapy was defined as line number (1; 2; 3; etc.) in the A/MBC setting assigned based on synapse line of therapy algorithm. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.

1 Line

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	100

2 Lines

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	21.49

3 Lines

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	12.81

4 Lines

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	2.07

5 Lines or more

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	3.31

Percentage of Participants With Their Starting Dose and End Dose Primary · From start of treatment to end of follow-up, up to a maximum of approximately 5 years

Percentage of participants with starting and end dose at 125 mg, 100 mg, 75 mg and unknown were reported.

Starting Dose: 125 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	89.7

Starting Dose: 100 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	7.4

Starting Dose: 75 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.2

Starting Dose: Unknown

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.7

End Dose: 125 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	60.7

End Dose: 100 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	27.7

End Dose: 75 mg

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	9.9

End Dose: Unknown

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.7

Percentage of Participants With Type of Dose Adjustment Primary · From start of treatment to end of follow-up, up to a maximum of approximately 5 years

In this outcome measure type of dose adjustments were recorded and reported. It included dose increase, decrease, no adjustment and unknown categories.

Increase

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.4

Decrease

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	31.0

No adjustment

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	66.9

Unknown

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.7

Percentage of Participants With Their Reason For Treatment Discontinuation Primary · From start of treatment to end of follow-up, up to a maximum of approximately 5 years

Percentage of participants with discontinuation reason as progression, intolerance/toxicity, participant choice, treatment for other diseases, left health system, end of planned therapy, changes in insurance, death, hospice referral, physician choice, actionable mutation found, other/unknown were recorded and reported in this outcome measure.

Progression

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	26.4

Intolerance/toxicity

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	14.9

Participant Choice

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	2.5

Treatment for Other Diseases

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	2.5

Left Health System

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0

End of Planned Therapy

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	2.1

Changes in Insurance

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.2

Death

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	1.2

Time to Dose Adjustment Primary · From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years

Time to dose adjustment (TTDA) was defined as the time from the start of palbociclib and AI treatment until the date of treatment dose adjustment.

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	55.0	1.000 – 1435

Probability of Real-World Progression-Free Survival (rwPFS) at Month 3 Primary · 3 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as disease progression \[PD\] or death due to any cause) at 3 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 3 months were reported in this

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.95	0.92 – 0.97

Probability of Real-World Progression-Free Survival (rwPFS) at Month 6 Primary · 6 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as PD or death due to any cause) at 6 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 6 months were reported in this outcome measure. Analysi

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.84	0.8 – 0.89

Probability of Real-World Progression-Free Survival (rwPFS) at Month 12 Primary · 12 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as PD or death due to any cause) at 12 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 12 months were reported in this outcome measure. Analy

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.75	0.7 – 0.81

Probability of Real-World Progression-Free Survival (rwPFS) at Month 18 Primary · 18 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as PD or death due to any cause) at 18 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 18 months were reported in this outcome measure. Analy

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.66	0.59 – 0.72

Probability of Real-World Progression-Free Survival (rwPFS) at Month 24 Primary · 24 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as PD or death due to any cause) at 24 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 24 months were reported in this outcome measure. Analy

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.59	0.53 – 0.67

Probability of Real-World Progression-Free Survival (rwPFS) at Month 30 Primary · 30 months after treatment initiation any time during 5 years of study period

Probability of being event free (event defined as PD or death due to any cause) at 30 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 30 months were reported in this outcome measure. Analy

Group	Value	95% CI
Palbociclib With Aromatase Inhibitor	0.53	0.46 – 0.61

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Law JW, Mitra D, Kaplan HG, Alfred T, et al · · 2022 · cited 14× · PMID 35200588 · DOI 10.3390/curroncol29020089

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04394247 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 21 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04394247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing