European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies (EUCHARIS)
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| ClinicalTrials.gov Identifier: NCT05043506 |
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Recruitment Status :
Active, not recruiting
First Posted : September 14, 2021
Last Update Posted : May 6, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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Brief Summary:
A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe
| Condition or disease | Intervention/treatment |
|---|---|
| Metastatic Breast Cancer | Drug: Palbociclib + aromatase inhibitor Drug: Aromatase inhibitor |
| Study Type : | Observational |
| Estimated Enrollment : | 2400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS) |
| Actual Study Start Date : | February 8, 2022 |
| Estimated Primary Completion Date : | March 29, 2024 |
| Estimated Study Completion Date : | March 29, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
Drug Information available for:
Palbociclib
| Group/Cohort | Intervention/treatment |
|---|---|
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Palbociclib + aromatase inhibitor
Adult patients with advanced breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between September 1, 2016, and July 31, 2020.
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Drug: Palbociclib + aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Other Name: Palbociclib + an aromatase inhibitor therapy |
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Aromatase inhibitor
Adult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020
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Drug: Aromatase inhibitor
Aromatase inhibitor monotherapy
Other Name: Aromatase inhibitor monotherapy |
Primary Outcome Measures :
- Real-world progression free survival [ Time Frame: Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring ]
Secondary Outcome Measures :
- Overall survival [ Time Frame: Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring ]
- Time to first objective tumor response [ Time Frame: Time from treatment line start date to clinician-assessed first date of objective response or date of censoring ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients with HR+/HER2- advanced breast cancer treated with palbociclib + an aromatase inhibitor or an aromatase inhibitor alone between January 1, 2010 to July 31, 2020
Criteria
Inclusion Criteria:
- Is male or female
- Has histologically or cytologically confirmed breast cancer diagnosis (HR+/HER2- breast cancer)
- Has received a diagnosis of locally advanced breast cancer not amenable to curative radiation or surgical cure or of metastatic breast cancer (i.e., advanced breast cancer [ABC]); diagnosis may be de novo (initial diagnosis at ABC stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease)
- Has initiated a required first-line therapy of interest: Palbociclib plus AI as first-line therapy for ABC between September 1, 2016, and July 31, 2020, or AI monotherapy as first-line therapy for ABC between January 1, 2010,, and July 31, 2020
- Was aged 18 years or older at the time of diagnosis of ABC
- Is living or deceased at the time of record abstraction
- Has a complete medical record, covering treatment for ABC, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction
Exclusion Criteria:
- The patient's first treatment after ABC diagnosis was chemotherapy (including induction chemotherapy)
- The patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of ABC; patients diagnosed with second primary cancer after ABC diagnosis will not be excluded
- The patient has evidence of prior treatment with any CDK4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the ABC setting
- The patient has participated in a clinical trial related to treatment of ABC (including after first-line therapy [i.e., palbociclib plus AI or AI monotherapy])
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043506
Locations
Show 53 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05043506 |
| Other Study ID Numbers: |
A5481170 EUCHARIS ( Other Identifier: Alias Study Number ) |
| First Posted: | September 14, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Pfizer:
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breast cancer Palbociclib Real-world data CDK4/6 effectiveness |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Palbociclib Aromatase Inhibitors Antineoplastic Agents |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |