A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Active, not recruiting

• Conditions: Breast Cancer; Malignant Neoplasm of Breast
• Interventions: Drug: Palbociclib; Drug: Aromatase inhibitor; Drug: Ribociclib; Drug: Abemaciclib

• Registration Number: NCT06495164
• Lead Sponsor: Pfizer

Brief Summary

Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-03
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5087

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abemaciclib plus aromatase inhibitor (AI)	Aromatase inhibitor	Oral abemaciclib plus AI treatment regimen as decided by physician
Ribociclib plus aromatase inhibitor (AI)	Aromatase inhibitor	Oral ribociclib plus AI as decided by physician
Aromatase inhibitor (AI)	Aromatase inhibitor	Oral AI treatment regimen as decided by physician
Palbociclib + aromatase inhibitor (AI)	Aromatase inhibitor	Oral palbociclib + AI combination treatment regimen as decided by physician
Palbociclib + aromatase inhibitor (AI)	Palbociclib	Oral palbociclib + AI combination treatment regimen as decided by physician
Abemaciclib plus aromatase inhibitor (AI)	Palbociclib	Oral abemaciclib plus AI treatment regimen as decided by physician
Abemaciclib plus aromatase inhibitor (AI)	Abemaciclib	Oral abemaciclib plus AI treatment regimen as decided by physician
Ribociclib plus aromatase inhibitor (AI)	Ribociclib	Oral ribociclib plus AI as decided by physician

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From start of index line of therapy to death, February 2015 - December 2022 or data cutoff

Secondary Outcome Measures

Name	Time	Method
Real Progression Free Survival (rwPFS)	From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff
Real-World Tumor Response (rwTR)	From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff
Duration of treatment	from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff
Time to chemotherapy	from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff
Progression Free Survival 2	from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff

Trial Locations

Locations (1)

Pfizer New York; 🇺🇸 New York, New York, United States