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Breast Cancer Stage IIPhase 2AppalachesNCT03609047

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

A Phase 2 study testing Palbociclib, Docetaxel / cyclophosphamide and doxorubicin/cyclophosphamide in people with Breast Cancer Stage II and Breast Cancer Stage III, run by European Organisation for Research and Treatment of Cancer - EORTC at 73 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Palbociclib, Docetaxel / cyclophosphamide and doxorubicin/cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
73 sitesin 9 countries
Study dates
14 Jun 2019to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

73 sites in 9 countries.

73 sites in 9 countries

Italy17 sites

  • Ospedale Degli Infermi

    Biella

  • Ospedale Generale Regionale

    Bolzano

  • Ospedale B. Ramazzini

    Carpi

  • Riccione Hospital Unit - Ospedale Cervesi di Cattolica

    Cattolica

  • Faenza Hospital Unit - Ospedale degli Infermi

    Faenza

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

    Genova

  • Ospedale Civile Guastalla

    Guastalla

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

    Legnago

  • Lugo Hospital Unit -Ospedale Umberto I

    Lugo

  • Azienda Ospedaliero - Universitaria Policlinico di Modena

    Modena

  • Ospedale San Gerardo

    Monza

  • Rimini Hospital Unit - Ospedale Sacra Famiglia

    Novafeltria

  • Casa di Cura La Maddalena S.P.A.

    Palermo

  • Ospedale Santa Maria delle Croci

    Ravenna

  • AUSL Romagna - Rimini Hospital Unit - Infermi Hospital

    Rimini

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

    Torino

  • Azienda Ospedaliero Universitaria - Ospedali Riuniti

    Torrette

Other trials in Italy

France14 sites

  • Institut Bergonie

    Bordeaux

  • CHU-Lyon - Hopital Femme Mere Enfant

    Brou

  • Centre Francois Baclesse (CLCC)

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Hospitalier Departemental Vendée

    La Roche-sur-Yon

  • Centre Oscar Lambret

    Lille

  • CHU de Limoges - Hopital Dupuytren

    Limoges

  • Centre Leon Berard

    Lyon

  • CHU de Lyon - Hopital De La Croix Rousse

    Lyon

  • Hospital prive du Confluent - Centre Catherine de Sienne

    Nantes

  • CHU de Lyon - Hopital Lyon Sud

    Pierre-Bénite

  • Centre Henri Becquerel

    Rouen

  • Institut Curie - l' Hopital de St Cloud

    Saint-Cloud

  • Institut Claudius Regaud

    Toulouse

Other trials in France

Spain14 sites

  • Hospital Clinic Universitari de Barcelona

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

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

    Barcelona

  • Hospital Universitari Arnau De Vilanova

    Lleida

  • Centro Oncológico MD Anderson

    Madrid

  • Hospital Severo Ochoa

    Madrid

  • Hospital Universitario 12 De Octubre

    Madrid

  • Hospital Universitario QuironSalud

    Madrid

  • Hospitales HM Sanchinarro-CIOCC

    Madrid

  • Hospital Sant Joan de Reus

    Reus

  • Hospital Universitario Virgen de Valme

    Seville

  • Virgen del Rocio University Hospital

    Seville

  • Fundacion Instituto Valenciano De Oncologia

    Valencia

  • Hospital Clinico Universitario De Valencia

    Valencia

Other trials in Spain

Germany10 sites

  • Kliniken Essen-Mitte

    Essen

  • Klinikum Frankfurt Hoechst GmbH

    Frankfurt am Main

  • Universitaetskliniken Des Saarlandes

    Homburg / Saar

  • ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz

    Offenburg

  • Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg

    Ravensburg

  • Marienkrankenhaus Schwerte

    Schwerte

  • Marienhospital Stuttgart

    Stuttgart

  • Kreiskrankenhaus Torgau

    Torgau

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen

  • Marienhospital Witten

    Witten

Other trials in Germany

Belgium8 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Institut Jules Bordet-Hopital Universitaire ULB

    Brussels

  • AZ Maria Middelares

    Ghent

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

  • C.H.U. Sart-Tilman

    Liège

  • Heilig Hartziekenhuis Lier

    Lier

  • AZ Nikolaas - Campus SL

    Sint-Niklaas

  • AZ Turnhout - Campus Sint Elisabeth

    Turnhout

Other trials in Belgium

United Kingdom4 sites

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

    Blackpool

  • NHS Lothian - Western General Hospital

    Edinburgh

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

    London

  • NHS Borders - Borders General Hospital Melrose By-pass

    Melrose

Other trials in United Kingdom

Portugal3 sites

  • Champalimaud Clinical Center

    Lisbon

  • Centro Hospitalar do Porto-- Hospital de Santo Antonio

    Porto

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

    Porto

Other trials in Portugal

Poland2 sites

  • Medical University Of Gdansk

    Gdansk

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

    Warsaw

Other trials in Poland

Jordan1 site

  • King Hussein Cancer Center

    Amman

Other trials in Jordan

About this study

Official title: A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer

Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

Read the detailed description

The primary objective of this trial is to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

This is a two-arm open-label multi-center randomized (2:1) non-comparative phase II study in elderly patients with stage II/III, ER+, HER2- early breast cancer for whom treatment with chemotherapy is indicated.

Patients will be randomized with a 2:1 allocation rate to the following treatment arm:

  • experimental palbociclib arm: Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib for a total duration of up to 2 years.
  • control chemotherapy arm: adjuvant chemotherapy (4 cycles of docetaxel/doxorubicin/epirubicin-cyclophosphamide; or of weekly paclitaxel D1, D8, and D15 q3w if a 3 weekly schedule is not desired), followed by standard adjuvant endocrine therapy for a duration of at least 5 years.

The primary endpoint of the study is the 3-year D-RFI rate in the experimental arm.

Being tested
Palbociclib, Docetaxel / cyclophosphamide, doxorubicin/cyclophosphamide, epirubicin/cyclophosphamide, paclitaxel
Keywords
Breast cancer, elderly patients, CDK4/6 inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    CDK4/6 inhibitor

  • Docetaxel / cyclophosphamideDrug

    Adjuvant Chemotherapy

  • doxorubicin/cyclophosphamideDrug

    Adjuvant Chemotherapy

  • epirubicin/cyclophosphamideDrug

    Adjuvant Chemotherapy

  • paclitaxelDrug

    Adjuvant Chemotherapy

Study groups in NCT03609047
Study groupRoleWhat they receive
experimental palbociclib armExperimentalStandard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib (one capsule 125mg QD, orally, for 21 days followed by 7 days off treatment) for a total duration of up to 2 years.
Receives: Drug: Palbociclib
control chemotherapy armActive comparatorAdjuvant chemotherapy: 4 cycles docetaxel 75 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles doxorubicin 60 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles epirubicin 90 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles weekly paclitaxel 80 mg/m2 D1, D8, and D15 q3w Followed by standard adjuvant endocrine therapy for a duration of at least 5 years.
Receives: Drug: Docetaxel / cyclophosphamide; Drug: doxorubicin/cyclophosphamide; Drug: epirubicin/cyclophosphamide; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. distant recurrence-free interval (D-RFI) rate

    Measured: 5 years after first patient inclusion

Secondary outcomes (3)

  1. Breast cancer specific survival

    Measured: 5 years after first patient inclusion

  2. Overall survival

    Measured: 5 years after first patient inclusion

  3. Incidence of permanent treatment discontinuation

    Measured: 5 years after first patient inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start14 Jun 2019
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized 2:1
Masking
None (open label)
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609047
Sponsor's protocol ID
EORTC 1745-ETF-BCG
Acronym
Appalaches
Status last verified
May 2026
First submitted
18 Jun 2018
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, Docetaxel / cyclophosphamide and doxorubicin/cyclophosphamide in people with Breast Cancer Stage II and Breast Cancer Stage III, run by European Organisation for Research and Treatment of Cancer - EORTC at 73 sites in 9 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 24 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Italy, France, Spain, Germany, Belgium and 4 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

distant recurrence-free interval (D-RFI) rate (time frame: 5 years after first patient inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03609047.

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 12 May 2026.

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