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Could a pill replace chemo for older breast cancer patients?

NCT ID NCT03609047

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a targeted therapy called palbociclib, taken for 2 years alongside standard hormone therapy, can help prevent breast cancer from coming back in older patients with high-risk ER+/HER2- early breast cancer. The goal is to offer an effective alternative to chemotherapy, which can be harder for older adults to tolerate. The trial involves 366 participants with stage II or III breast cancer.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 366 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 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: * Women or men with stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification * Histologically confirmed Estrogen Receptor ER+ (at least 10 % of cells staining positive for ER), Human Epidermal Growth Factor Receptor 2 (HER-2) negative, early invasive breast cancer based on results of local pathology. Testing may be performed on diagnostic core biopsy or resection specimen. * In patients with multicentric, multifocal and/or bilateral breast cancer, all histopathologically examined invasive tumors must meet pathologic criteria regarding ER and HER2-status described above. * Adjuvant chemotherapy indicated and feasible according to treating physician and patient, based on standard clinicopathological parameters (tumor size, lymph node involvement, general health status, proliferation marker, patient wish) and gene expression profile if available. * Adjuvant chemotherapy combining both anthracycline and taxanes considered not indicated or not feasible according to treating physician. * No evidence of macroscopic distant metastases, investigated according to local institutional guidelines. * Age ≥70 years * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy ≤8 weeks before randomization. * The maximum duration from last surgery to the start of the first adjuvant treatment is 9 weeks. * Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization. * Incentive to undergo adjuvant radiation therapy when indicated per local institutional guidelines. * Note: For patients in the palbociclib arm, radiation therapy when indicated has to start ≤9 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. Palbociclib has to start ≤3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated ≤9 weeks after last surgery. * Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start ≤9 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start ≤6 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated ≤6 weeks after last chemotherapy administration. * Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to inclusion: * Hemoglobin ≥ 9 g/dL * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet count ≥ 100,000/mm3 * Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 × ULN in patients with documented Gilbert's Syndrome. * Glomerular Filtration Rate (GFR) ≥ 30 ml/min according to Modification of Diet in Renal Disease (MDRD) formula or Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula or Cockcroft and Gault formula * Serum Glutamic Oxaloacetic Transaminase (Aspartate Transaminase), Serum Glutamic Pyruvic Transaminase (Alanine Transaminase) and alkaline phosphatase ≤ 2.5 × ULN * Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration/randomization, written informed consent must be obtained according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Previous history of invasive breast cancer * Systemic anticancer therapy prior to the breast cancer surgery * Prior therapy with any Cyclin-Dependent Kinase (CDK)4/6 inhibitor * Concurrent investigational agent within 28 days of randomization * Concomitant anticancer treatment with the exception of bone antiresorptive agents or Luteinizing Hormone-Releasing Hormone agonists in male patients treated with an aromatase-inhibitor * History of allergic reactions attributed to compounds of chemical or biological composition similar to palbociclib or to chemotherapy components * Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Chapter 5.6.3 for list of CYP3A inhibitors and inducers) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes. * Other malignancy within the last 5 years except: adequately treated non-metastatic non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer stage II Breast cancer stage III

Contacts and locations

Locations

  • AULSS 9 - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

    Legnago, Italy

  • AUSL Romagna - Rimini Hospital Unit - Infermi Hospital

    Rimini, Italy

  • AZ Maria Middelares

    Ghent, Belgium

  • AZ Nikolaas - Campus SL

    Sint-Niklaas, Belgium

  • AZ Turnhout - Campus Sint Elisabeth

    Turnhout, Belgium

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

    Torino, Italy

  • Azienda Ospedaliero - Universitaria Policlinico di Modena

    Modena, Italy

  • Azienda Ospedaliero Universitaria - Ospedali Riuniti

    Torrette, Italy

  • Barts Health NHS Trust - St. Bartholomew'S Hospital

    London, United Kingdom

  • Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital-NHS Fundation Trust

    Blackpool, United Kingdom

  • C.H.U. Sart-Tilman

    Liège, Belgium

  • CHU de Limoges - Hopital Dupuytren

    Limoges, France

  • CHU de Lyon - Hopital De La Croix Rousse

    Lyon, France

  • CHU de Lyon - Hopital Lyon Sud

    Pierre-Bénite, France

  • CHU-Lyon - Hopital Femme Mere Enfant

    Brou, France

  • Casa di Cura La Maddalena S.P.A.

    Palermo, Italy

  • Centre Francois Baclesse (CLCC)

    Caen, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Departemental Vendée

    La Roche-sur-Yon, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Leon Berard

    Lyon, France

  • Centre Oscar Lambret

    Lille, France

  • Centro Hospitalar do Porto-- Hospital de Santo Antonio

    Porto, Portugal

  • Centro Oncológico MD Anderson

    Madrid, Spain

  • Champalimaud Clinical Center

    Lisbon, Portugal

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Faenza Hospital Unit - Ospedale degli Infermi

    Faenza, Italy

  • Fundacion Instituto Valenciano De Oncologia

    Valencia, Spain

  • Heilig Hartziekenhuis Lier

    Lier, Belgium

  • Hospital Clinic Universitari de Barcelona

    Barcelona, Spain

  • Hospital Clinico Universitario De Valencia

    Valencia, Spain

  • Hospital Sant Joan de Reus

    Reus, Spain

  • Hospital Severo Ochoa

    Madrid, Spain

  • Hospital Universitari Arnau De Vilanova

    Lleida, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, Spain

  • Hospital Universitario QuironSalud

    Madrid, Spain

  • Hospital Universitario Virgen de Valme

    Seville, Spain

  • Hospital prive du Confluent - Centre Catherine de Sienne

    Nantes, France

  • Hospitales HM Sanchinarro-CIOCC

    Madrid, Spain

  • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST

    Genova, Italy

  • Institut Bergonie

    Bordeaux, France

  • Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

    Barcelona, Spain

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie - l' Hopital de St Cloud

    Saint-Cloud, France

  • Institut Jules Bordet-Hopital Universitaire ULB

    Brussels, Belgium

  • Instituto Portugues De Oncologia - Instituto Portugues de Oncologia do Porto

    Porto, Portugal

  • King Hussein Cancer Center

    Amman, Jordan

  • Kliniken Essen-Mitte

    Essen, Germany

  • Klinikum Frankfurt Hoechst GmbH

    Frankfurt am Main, Germany

  • Kreiskrankenhaus Torgau

    Torgau, Germany

  • Lugo Hospital Unit -Ospedale Umberto I

    Lugo, Italy

  • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute

    Warsaw, Poland

  • Marienhospital Stuttgart

    Stuttgart, Germany

  • Marienhospital Witten

    Witten, Germany

  • Marienkrankenhaus Schwerte

    Schwerte, Germany

  • Medical University Of Gdansk

    Gdansk, Poland

  • NHS Borders - Borders General Hospital Melrose By-pass

    Melrose, United Kingdom

  • NHS Lothian - Western General Hospital

    Edinburgh, United Kingdom

  • ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz

    Offenburg, Germany

  • Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg

    Ravensburg, Germany

  • Ospedale B. Ramazzini

    Carpi, Italy

  • Ospedale Civile Guastalla

    Guastalla, Italy

  • Ospedale Degli Infermi

    Biella, Italy

  • Ospedale Generale Regionale

    Bolzano, Italy

  • Ospedale San Gerardo

    Monza, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, Italy

  • Riccione Hospital Unit - Ospedale Cervesi di Cattolica

    Cattolica, Italy

  • Rimini Hospital Unit - Ospedale Sacra Famiglia

    Novafeltria, Italy

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, Germany

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven, Belgium

  • Universitaetskliniken Des Saarlandes

    Homburg / Saar, Germany

  • Virgen del Rocio University Hospital

    Seville, Spain

More trials for these conditions

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