Metastatic Breast CancerEUCHARISNCT05043506
European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
An observational study of Metastatic Breast Cancer, run by Pfizer at 64 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib + aromatase inhibitor and Aromatase inhibitor
- How many people
- 1,939 participants
- Where
- 64 sitesin 7 countries
- Study dates
- 8 Feb 2022to 2 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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])
Trial locations and contacts
64 sites in 7 countries.
64 sites in 7 countries
Spain20 sites
Complejo Universitario de Albacete
Albacete, 02006
Hospital Universitario de Basurto
Bilbao, Bizkaia, 48013
Hospital Universitario de Puerto Real
Cadiz, Andalusia, 11510
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Institut Catalâ Oncologia-L'Hospitalet
L'Hospitalet de Llobregat, Barcelona [barcelona], 08908
Complejo Asistencial Universitario de Leon
León, 24007
Hospital Universitario La Paz
Madrid, 28046
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital General Universitario Morales Meseguer
Murcia, Comunidad de Murcia, 30008
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital de Sagunto
Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, 46520
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Santiago de Compostela/cantabria, 15706
Hospital Universitario Virgen Del Rocio
Seville, Sevila, 41013
Hospital nuestra señora del prado de Toledo
Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, 45600
Hospital de Sant Pau i Santa Tecla
Tarragona, 43003
Hospital Universitario Dr. Peset
Valencia, 46017
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Cantabria Castilla Y LEON, 36211
Hospital San Jorge Huesca
Zaragoza, Huesca/ Aragon, 50009
United Kingdom17 sites
Ysbyty Gwynedd Hospital
Bangor, Gwynedd, LL57 2PW
Royal United Hospital Bath NHS Trust
Bath, BA1 3NG
Royal Blackburn Hospital
Blackburn, BB2 3HH
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, BD9 6RJ
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
Buckinghamshire, Buckinghamshire, HP7 0JD
Royal Cornwall Hospital
Cornwall, TR1 3LJ
Beatson West of Scotland Cancer Centre
Glasglow, Glasglow City, Scotland, G12 0YH
Airedale NHS Foundation Trust
Keighley, WEST Yorkshire, BD20 6TD
Queen Elizabeth Hospital
Kings Lynn, Norfolk, PE30 4ET
Nottingham University Hospitals NHS Trust
Nottingham, GGS 1PB
Glan Clwyd Hospital
Rhyl, Denbighshire, LL18 5UJ
Borders General Hospital
Roxburghshire, Scotland, TD6 9BS
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, SY3 8XQ
Forth Valley Royal Hospital
Stirling, Scotland, FK9 4SW
Western General Hospital
Waterloo Place, Edinburgh, EH1 3EG
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
Germany16 sites
MediOnko-Institut GbR
Berlin, Brandenburg, 13597
Group practice Goehler
Dresden, 01127
Studienzentrum UnterEms
Emden, Saxony, 26721
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Bethanien Center for Hematology and Oncology
Frankfurt, 60389
Überörtliche Gemeinschaftspraxis
Hamburg, 48415
Frauenarztpraxis
Ilsede, Peine, D-31241
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Institut für Versorgungsforschung GbR
Mainz, Rhineland-Palatinate, 55116
Ruppiner Kliniken GmbH
Neuruppin, Ostprignitz-ruppin, 16816
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098
Universität des Saarlandes
Saarbrücken, Saarland, 66123
Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
Sindelfingen, Landkreis Boblingen, 71065
Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
Stralsund, 18439
Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, 26655
Universitätsklinikum Würzburg Frauenklinik und Poliklinik
Würzburg, Bavaria, 97080
Austria4 sites
Sankt Josef Hospital Braunau
Braunau am Inn, 5280
Landesklinikum Krems
Krems, 3500
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100
Priv. Doz. OA Dr. Michael Hubalek
Schwaz, 6130
Sweden4 sites
St Goran Hospital
Bromma, 167 56
Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], 631 88
Örebro University Hospital
Örebro, 70286
Uppsala University Hospital
Uppsala, 751 85
Switzerland2 sites
Kantonsspital Baden AG
Baden, 5404
Kantonsspital Baselland
Liestal
About this study
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)
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
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib + aromatase inhibitor, Aromatase inhibitor
- Keywords
- breast cancer, Palbociclib, Real-world data, CDK4/6, effectiveness
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib + aromatase inhibitorDrug
Also called Palbociclib + an aromatase inhibitor therapy
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitorDrug
Also called Aromatase inhibitor monotherapy
Aromatase inhibitor monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Palbociclib + aromatase inhibitor | |
| 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 Receives: Drug: Aromatase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world progression free survival
Total time from the treatment line start date to the date of disease progression confirmed by clinician assessment or the date of censoring, as measured in months
Measured: From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months
Secondary outcomes (2)
Overall survival
Time from the treatment line start to the date of confirmed death, or the date of censoring
Measured: From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months
Time to first objective tumor response
Time from the date of treatment line start to the first date of clinician-assessed objective response, or the date of censoring, measured in months
Measured: From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start8 Feb 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,939 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043506
- Sponsor's protocol ID
- A5481170
- Other IDs
- EUCHARIS
- Acronym
- EUCHARIS
- Status last verified
- May 2026
- First submitted
- 7 Sep 2021
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05043506
- Acronym / sponsor ID
- EUCHARIS / A5481170
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, Palbociclib, Real-world data, CDK4/6, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,939 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + aromatase inhibitor | – | Drug: Palbociclib + aromatase inhibitorAdult patients with advanced breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between September 1, 2016, and July 31, 2020. |
| Aromatase inhibitor | – | Drug: Aromatase inhibitorAdult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbociclib + aromatase inhibitorAlso: Palbociclib + an aromatase inhibitor therapyPalbociclib + an aromatase inhibitor therapy | Drug | Palbociclib + aromatase inhibitor |
| Aromatase inhibitorAlso: Aromatase inhibitor monotherapyAromatase inhibitor monotherapy | Drug | Aromatase inhibitor |
Primary outcome
Real-world progression free survival
Time frame: From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months
Total time from the treatment line start date to the date of disease progression confirmed by clinician assessment or the date of censoring, as measured in months
2 secondary outcomes
Overall survival
Time frame: From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months
Time to first objective tumor response
Time frame: From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
64 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Pfizer at 64 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Spain, United Kingdom, Germany, Austria, Sweden and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world progression free survival (time frame: From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.