Real-world data may reveal true effectiveness of leading breast cancer therapy
NCT ID NCT05043506
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study looks at medical records from across Europe to see how well a drug combination (palbociclib plus an aromatase inhibitor) works as a first treatment for people with a common type of advanced breast cancer (HR+/HER2-). Researchers want to understand how long the treatment keeps the cancer from getting worse and how long people live. The study does not give any new treatments—it simply observes what happens in real-world clinics.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Palbociclib plus an aromatase inhibitor
- What this could lead to
- If successful, this study could confirm that palbociclib plus an aromatase inhibitor works well in everyday clinical practice, not just in controlled trials.
- What could go wrong
- This is an observational study, not a controlled experiment, so results may be influenced by factors like patient selection or differences in care across countries.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,939 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Nov 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[i.e., palbociclib plus AI or AI monotherapy\])
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Airedale NHS Foundation Trust
Keighley, WEST Yorkshire, BD20 6TD, United Kingdom
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Beatson West of Scotland Cancer Centre
Glasglow, Glasglow City, Scotland, G12 0YH, United Kingdom
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Bethanien Center for Hematology and Oncology
Frankfurt, 60389, Germany
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Borders General Hospital
Roxburghshire, Scotland, TD6 9BS, United Kingdom
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Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, BD9 6RJ, United Kingdom
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Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
Buckinghamshire, Buckinghamshire, HP7 0JD, United Kingdom
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Complejo Asistencial Universitario de Leon
León, 24007, Spain
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Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Cantabria Castilla Y LEON, 36211, Spain
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Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
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Complejo Universitario de Albacete
Albacete, 02006, Spain
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Forth Valley Royal Hospital
Stirling, Scotland, FK9 4SW, United Kingdom
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Frauenarztpraxis
Ilsede, Peine, D-31241, Germany
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Glan Clwyd Hospital
Rhyl, Denbighshire, LL18 5UJ, United Kingdom
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Group practice Goehler
Dresden, 01127, Germany
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Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
Stralsund, 18439, Germany
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Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Santiago de Compostela/cantabria, 15706, Spain
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Hospital General Universitario Morales Meseguer
Murcia, Comunidad de Murcia, 30008, Spain
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Hospital Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
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Hospital San Jorge Huesca
Zaragoza, Huesca/ Aragon, 50009, Spain
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Hospital Universitario Dr. Peset
Valencia, 46017, Spain
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Hospital Universitario La Paz
Madrid, 28046, Spain
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Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
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Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
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Hospital Universitario Virgen Del Rocio
Seville, Sevila, 41013, Spain
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Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
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Hospital Universitario de Basurto
Bilbao, Bizkaia, 48013, Spain
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Hospital Universitario de Puerto Real
Cadiz, Andalusia, 11510, Spain
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Hospital de Sagunto
Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, 46520, Spain
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Hospital de Sant Pau i Santa Tecla
Tarragona, 43003, Spain
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Hospital nuestra señora del prado de Toledo
Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, 45600, Spain
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Institut Catalâ Oncologia-L'Hospitalet
L'Hospitalet de Llobregat, Barcelona [barcelona], 08908, Spain
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Institut für Versorgungsforschung GbR
Mainz, Rhineland-Palatinate, 55116, Germany
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Kantonsspital Baden AG
Baden, 5404, Switzerland
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Kantonsspital Baselland
Liestal, Switzerland
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Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
Sindelfingen, Landkreis Boblingen, 71065, Germany
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Landesklinikum Krems
Krems, 3500, Austria
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MediOnko-Institut GbR
Berlin, Brandenburg, 13597, Germany
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Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, 26655, Germany
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Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], 631 88, Sweden
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Nottingham University Hospitals NHS Trust
Nottingham, GGS 1PB, United Kingdom
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Priv. Doz. OA Dr. Michael Hubalek
Schwaz, 6130, Austria
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Queen Elizabeth Hospital
Kings Lynn, Norfolk, PE30 4ET, United Kingdom
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Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
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Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
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Royal Cornwall Hospital
Cornwall, TR1 3LJ, United Kingdom
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Royal United Hospital Bath NHS Trust
Bath, BA1 3NG, United Kingdom
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Ruppiner Kliniken GmbH
Neuruppin, Ostprignitz-ruppin, 16816, Germany
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Sankt Josef Hospital Braunau
Braunau am Inn, 5280, Austria
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Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
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St Goran Hospital
Bromma, 167 56, Sweden
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St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
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Studienzentrum UnterEms
Emden, Saxony, 26721, Germany
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UZ Leuven
Leuven, 3000, Belgium
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Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100, Austria
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Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
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Universität des Saarlandes
Saarbrücken, Saarland, 66123, Germany
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Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
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Universitätsklinikum Würzburg Frauenklinik und Poliklinik
Würzburg, Bavaria, 97080, Germany
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Uppsala University Hospital
Uppsala, 751 85, Sweden
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Western General Hospital
Waterloo Place, Edinburgh, EH1 3EG, United Kingdom
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Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD, United Kingdom
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Ysbyty Gwynedd Hospital
Bangor, Gwynedd, LL57 2PW, United Kingdom
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Örebro University Hospital
Örebro, 70286, Sweden
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Überörtliche Gemeinschaftspraxis
Hamburg, 48415, Germany
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Other studies related to the condition(s) this trial covers.
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