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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03609047
Other study ID # EORTC 1745-ETF-BCG
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 14, 2019
Est. completion date September 30, 2032

Study information

Verified date January 2024
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 366
Est. completion date September 30, 2032
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Palbociclib
CDK4/6 inhibitor
Docetaxel / cyclophosphamide
Adjuvant Chemotherapy
doxorubicin/cyclophosphamide
Adjuvant Chemotherapy
epirubicin/cyclophosphamide
Adjuvant Chemotherapy
paclitaxel
Adjuvant Chemotherapy

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Institut Jules Bordet-Hopital Universitaire ULB Brussels
Belgium AZ Maria Middelares Gent
Belgium U.Z. Leuven - Campus Gasthuisberg Leuven
Belgium C.H.U. Sart-Tilman Liège
Belgium Heilig Hartziekenhuis Lier Lier
Belgium AZ Nikolaas - Campus SL Sint-Niklaas
Belgium AZ Turnhout - Campus Sint Elisabeth Turnhout
France Institut Bergonie Bordeaux
France CHU-Lyon - Hopital Femme Mere Enfant Brou
France Centre Francois Baclesse (CLCC) Caen
France Centre Jean Perrin Clermont Ferrand
France Centre Hospitalier Departemental Vendée La Roche-sur-Yon
France Centre Oscar Lambret Lille
France CHU de Limoges - Hopital Dupuytren Limoges
France Centre Leon Berard Lyon
France CHU de Lyon - Hopital De La Croix Rousse Lyon
France Hospital prive du Confluent - Centre Catherine de Sienne Nantes
France CHU de Lyon - Hopital Lyon Sud Pierre-Bénite
France Centre Henri Becquerel Rouen
France Institut Curie - l' Hopital de St Cloud Saint-Cloud
France Institut Claudius Regaud Toulouse
Germany Kliniken Essen-Mitte Essen
Germany Klinikum Frankfurt Hoechst GmbH Frankfurt Am Main
Germany Universitaetskliniken Des Saarlandes Homburg / Saar
Germany ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz Offenburg
Germany Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg Ravensburg
Germany Marienkrankenhaus Schwerte Schwerte
Germany Marienhospital Stuttgart Stuttgart
Germany Kreiskrankenhaus Torgau Torgau
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen
Germany Marienhospital Witten Witten
Italy Ospedale Degli Infermi Biella
Italy Ospedale Generale Regionale Bolzano
Italy Ospedale B. Ramazzini Carpi
Italy Riccione Hospital Unit - Ospedale Cervesi di Cattolica Cattolica
Italy Faenza Hospital Unit - Ospedale degli Infermi Faenza
Italy IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST Genova
Italy Ospedale Civile Guastalla Guastalla
Italy AULSS 9 - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital Legnago
Italy Lugo Hospital Unit -Ospedale Umberto I Lugo
Italy Azienda Ospedaliero - Universitaria Policlinico di Modena Modena
Italy Ospedale San Gerardo Monza
Italy Rimini Hospital Unit - Ospedale Sacra Famiglia Novafeltria
Italy Casa di Cura La Maddalena S.P.A. Palermo
Italy Ospedale Santa Maria delle Croci Ravenna
Italy AUSL Romagna - Rimini Hospital Unit - Infermi Hospital Rimini
Italy 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 - Ospedali Riuniti Torrette
Jordan King Hussein Cancer Center Amman
Poland Medical University Of Gdansk Gdansk
Poland Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute Warsaw
Portugal Champalimaud Clinical Center Lisboa
Portugal Centro Hospitalar do Porto-- Hospital de Santo Antonio Porto
Portugal Instituto Portugues De Oncologia - Instituto Portugues de Oncologia do Porto Porto
Spain Hospital Clinic Universitari de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro Barcelona
Spain Hospital Universitari Arnau De Vilanova Lleida
Spain Centro Oncológico MD Anderson Madrid
Spain Hospital Severo Ochoa Madrid
Spain Hospital Universitario 12 De Octubre Madrid
Spain Hospital Universitario QuironSalud Madrid
Spain Hospitales HM Sanchinarro-CIOCC Madrid
Spain Hospital Sant Joan de Reus Reus
Spain Hospital Universitario Virgen de Valme Sevilla
Spain Virgen del Rocio University Hospital Sevilla
Spain Fundacion Instituto Valenciano De Oncologia Valencia
Spain Hospital Clinico Universitario De Valencia Valencia
United Kingdom Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital-NHS Fundation Trust Blackpool
United Kingdom NHS Lothian - Western General Hospital Edinburgh
United Kingdom Barts Health NHS Trust - St. Bartholomew'S Hospital London
United Kingdom NHS Borders - Borders General Hospital Melrose By-pass Melrose

Sponsors (9)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC Breast International Group, ETOP IBCSG Partners Foundation, German Adjuvant Breast Cancer Group, Gruppo Oncologico Italiano di Ricerca Clinica, Pfizer, SOLTI Breast Cancer Research Group, Swedish Association of Breast Oncologists, UNICANCER

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Jordan,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary distant recurrence-free interval (D-RFI) rate 5 years after first patient inclusion
Secondary Breast cancer specific survival 5 years after first patient inclusion
Secondary Overall survival 5 years after first patient inclusion
Secondary Incidence of permanent treatment discontinuation 5 years after first patient inclusion
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