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Real-world data may reveal true effectiveness of leading breast cancer therapy

NCT ID NCT05043506

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

1,939 people

The number who actually took part.

Started

Feb 2022

Finished

Nov 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Airedale NHS Foundation Trust

    Keighley, WEST Yorkshire, BD20 6TD, United Kingdom

  • Beatson West of Scotland Cancer Centre

    Glasglow, Glasglow City, Scotland, G12 0YH, United Kingdom

  • Bethanien Center for Hematology and Oncology

    Frankfurt, 60389, Germany

  • Borders General Hospital

    Roxburghshire, Scotland, TD6 9BS, United Kingdom

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, WEST Yorkshire, BD9 6RJ, United Kingdom

  • Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital

    Buckinghamshire, Buckinghamshire, HP7 0JD, United Kingdom

  • Complejo Asistencial Universitario de Leon

    León, 24007, Spain

  • Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, Cantabria Castilla Y LEON, 36211, Spain

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Universitario de Albacete

    Albacete, 02006, Spain

  • Forth Valley Royal Hospital

    Stirling, Scotland, FK9 4SW, United Kingdom

  • Frauenarztpraxis

    Ilsede, Peine, D-31241, Germany

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, LL18 5UJ, United Kingdom

  • Group practice Goehler

    Dresden, 01127, Germany

  • Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher

    Stralsund, 18439, Germany

  • Hospital Clínico de Santiago de Compostela

    Santiago de Compostela, Santiago de Compostela/cantabria, 15706, Spain

  • Hospital General Universitario Morales Meseguer

    Murcia, Comunidad de Murcia, 30008, Spain

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital San Jorge Huesca

    Zaragoza, Huesca/ Aragon, 50009, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevila, 41013, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario de Basurto

    Bilbao, Bizkaia, 48013, Spain

  • Hospital Universitario de Puerto Real

    Cadiz, Andalusia, 11510, Spain

  • Hospital de Sagunto

    Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, 46520, Spain

  • Hospital de Sant Pau i Santa Tecla

    Tarragona, 43003, Spain

  • Hospital nuestra señora del prado de Toledo

    Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, 45600, Spain

  • Institut Catalâ Oncologia-L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona [barcelona], 08908, Spain

  • Institut für Versorgungsforschung GbR

    Mainz, Rhineland-Palatinate, 55116, Germany

  • Kantonsspital Baden AG

    Baden, 5404, Switzerland

  • Kantonsspital Baselland

    Liestal, Switzerland

  • Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen

    Sindelfingen, Landkreis Boblingen, 71065, Germany

  • Landesklinikum Krems

    Krems, 3500, Austria

  • MediOnko-Institut GbR

    Berlin, Brandenburg, 13597, Germany

  • Medizinische Studiengesellschaft NORD-WEST GmbH

    Westerstede, 26655, Germany

  • Mälarsjukhuset

    Eskilstuna, Södermanlands LÄN [se-04], 631 88, Sweden

  • Nottingham University Hospitals NHS Trust

    Nottingham, GGS 1PB, United Kingdom

  • Priv. Doz. OA Dr. Michael Hubalek

    Schwaz, 6130, Austria

  • Queen Elizabeth Hospital

    Kings Lynn, Norfolk, PE30 4ET, United Kingdom

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH, United Kingdom

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Cornwall Hospital

    Cornwall, TR1 3LJ, United Kingdom

  • Royal United Hospital Bath NHS Trust

    Bath, BA1 3NG, United Kingdom

  • Ruppiner Kliniken GmbH

    Neuruppin, Ostprignitz-ruppin, 16816, Germany

  • Sankt Josef Hospital Braunau

    Braunau am Inn, 5280, Austria

  • Shrewsbury and Telford Hospital NHS Trust

    Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

  • St Goran Hospital

    Bromma, 167 56, Sweden

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098, Germany

  • Studienzentrum UnterEms

    Emden, Saxony, 26721, Germany

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Sankt Poelten

    Sankt Pölten, 3100, Austria

  • Universitatsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universität des Saarlandes

    Saarbrücken, Saarland, 66123, Germany

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Würzburg Frauenklinik und Poliklinik

    Würzburg, Bavaria, 97080, Germany

  • Uppsala University Hospital

    Uppsala, 751 85, Sweden

  • Western General Hospital

    Waterloo Place, Edinburgh, EH1 3EG, United Kingdom

  • Wrexham Maelor Hospital

    Wrexham, Wales, LL13 7TD, United Kingdom

  • Ysbyty Gwynedd Hospital

    Bangor, Gwynedd, LL57 2PW, United Kingdom

  • Örebro University Hospital

    Örebro, 70286, Sweden

  • Überörtliche Gemeinschaftspraxis

    Hamburg, 48415, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.