Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

NCT04460911 | Completed Results

• 2 other identifiers: A5481128US oncology
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (8)

• Time to Chemotherapy

  Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.

  From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Number of Participants According to Reasons for Treatment Discontinuation

  The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.

  From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Real-World Duration of Treatment (rwDOT)

  Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.

  From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Time to Next Treatment (TTNT) From Index Treatment

  Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.

  From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Percentage of Participants With Provider Documented Disease Progression

  Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.

  From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Real-World Time to Tumor Progression (rwTTP)

  The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.

  From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Real-World Progression-Free Survival (rwPFS)

  The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.

  From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Overall Survival (OS)

  Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.

  From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

Other Outcomes (5)

• Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment

  At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study)

• Duration of Treatment for Advanced Metastatic Breast Cancer

  From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

• Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer

  Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study)

Study Arms (1)

PAL + FUL

Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.

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

Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting

You may qualify if:

• Documented diagnosis of HR+/HER2- mBC
• Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
• Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes

You may not qualify if:

• Enrollment in an interventional clinical trial during the study period
• Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
• Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer United States

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@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: July 6, 2020
• First Posted: July 8, 2020
• Study Start: October 19, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)