Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

NCT05361655 | Completed Results

• 1 other identifier: A5481151
• Study Type: observational
• Target: 2,888
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.

Conditions

Metastatic Breast Cancer

Keywords

cyclin-dependent kinase 4/6i (CDK4/6i)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer

  OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used.

  From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months)

Secondary Outcomes (9)

• Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer

  From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months)

• Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer

  From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months)

• Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer

  From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months)

• Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only

  At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months)

• Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only

  At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months)

Study Arms (2)

Palbociclib + an aromatase inhibitor

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.

Drug: Palbociclib + an aromatase inhibitor

Aromatase inhibitor

Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.

Drug: Aromatase inhibitor

Interventions

Palbociclib + an aromatase inhibitor DRUG

Palbociclib + an aromatase inhibitor therapy

Palbociclib + an aromatase inhibitor

Aromatase inhibitor DRUG

Aromatase inhibitor therapy

Aromatase inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HR+/HER2- MBC adult patients treated with Palbociclib + AI or AI alone between February2015 and September, 2020

You may qualify if:

• Confirmed HR+/HER2- status after MBC diagnosis.
• Received palbociclib + AI or AI as first-line therapy

You may not qualify if:

• Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC
• First structured activity greater than 90 days after MBC diagnostic date
• Treatment with a CDK4/6 inhibitor as part of a clinical trial

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

10017

New York, New York, 10017, United States

Location

Related Publications (6)

• Layman RM, Liu X, Li B, McRoy L, Brufsky A. Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2- metastatic breast cancer: A Flatiron Health database analysis. Breast. 2025 Jun;81:104448. doi: 10.1016/j.breast.2025.104448. Epub 2025 Mar 17.

  PMID: 40138984 DERIVED

• Brufsky A, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Rugo HS. Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness. Oncologist. 2024 Dec 6;29(12):1032-1043. doi: 10.1093/oncolo/oyae273.

  PMID: 39418346 DERIVED

• Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Tomlin-Harris T, Brufsky A. Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: a plain language summary of a real-world database study. Future Oncol. 2024;20(19):1299-1307. doi: 10.2217/fon-2023-1079. Epub 2024 Mar 22.

  PMID: 38517416 DERIVED

• Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Brufsky A. Real-World Effectiveness of Palbociclib Plus Aromatase Inhibitors in African American Patients With Metastatic Breast Cancer. Oncologist. 2023 Oct 3;28(10):866-874. doi: 10.1093/oncolo/oyad209.

  PMID: 37487056 DERIVED

• Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Prolonging the life of people with metastatic breast cancer in routine clinical practice by adding palbociclib to an aromatase inhibitor from a real-world database analysis: a plain language summary. Future Oncol. 2023 Mar;19(7):489-498. doi: 10.2217/fon-2022-1192. Epub 2023 Mar 9.

  PMID: 36892508 DERIVED

• Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer. 2022 Oct 11;8(1):114. doi: 10.1038/s41523-022-00479-x.

  PMID: 36220852 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)