Clinical trial • Phase II • Oncology

palbociclib for Early estrogen receptor-positive (ER+) breast cancer

Phase II trial of palbociclib for Early estrogen receptor-positive (ER+) breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Early estrogen receptor-positive (ER+) breast cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-12-2023
First CTIS Authorization Date
21-02-2024

Trial design

Randomised, adjuvant chemotherapy comparator arms using anthracycline- and taxane-containing regimens: epirubicin (epirubicin hydrochloride) up to 90 mg/m2 iv; doxorubicin (doxorubicin) up to 60 mg/m2 iv; docetaxel (docetaxel) up to 75 mg/m2 iv; paclitaxel (paclitaxel) up to 80 mg/m2 iv; cyclophosphamide (cyclophosphamide) up to 600 mg/m2 iv. specific schedules/regimens not further specified in the ctis record.-controlled Phase II trial across 49 sites in Belgium, France, Germany and others.

Randomised
Yes
Comparator
Adjuvant chemotherapy comparator arms using anthracycline- and taxane-containing regimens: Epirubicin (EPIRUBICIN HYDROCHLORIDE) up to 90 mg/m2 IV; Doxorubicin (DOXORUBICIN) up to 60 mg/m2 IV; Docetaxel (DOCETAXEL) up to 75 mg/m2 IV; Paclitaxel (PACLITAXEL) up to 80 mg/m2 IV; Cyclophosphamide (CYCLOPHOSPHAMIDE) up to 600 mg/m2 IV. Specific schedules/regimens not further specified in the CTIS record.
Target Sample Size
347
Trial Duration For Participant
1825

Eligibility

Recruits 347 The trial enrolls older adults (age ≥70 years). Participation requires signed, written informed consent from the patient. Participation in mandatory translational research requires explicit patient consent for sequential blood sampling. No paediatric or other vulnerable populations are selected (isVulnerablePopulationSelected: false); assent from minors is not applicable..

Vulnerable Population
The trial enrolls older adults (age ≥70 years). Participation requires signed, written informed consent from the patient. Participation in mandatory translational research requires explicit patient consent for sequential blood sampling. No paediatric or other vulnerable populations are selected (isVulnerablePopulationSelected: false); assent from minors is not applicable.

Inclusion criteria

  • {"criterion_text":"-Women or men with pathologic stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification"}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-Adjuvant chemotherapy with both anthracycline and taxanes (in combination or in sequence) considered not indicated or not feasible according to treating physician."}
  • {"criterion_text":"-Age ≥70 years"}
  • {"criterion_text":"-WHO Performance status 0-2"}
  • {"criterion_text":"-Completed G8 geriatric assessment within 3 weeks of randomization"}
  • {"criterion_text":"-Participation in translational research is mandatory and therefore patient must consent for it. Patient should allow sequential sampling of blood during the course of the trial"}
  • {"criterion_text":"-Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption."}
  • {"criterion_text":"-Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy ≤12 weeks before randomization. The final primary tumor surgical specimen must have R0 margins free from tumor."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-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 ≤13 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. Palbociclib has to start ≤4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated ≤13 weeks after last surgery. Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start ≤ 13 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start ≤9 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated ≤6 weeks after last chemotherapy administration."}
  • {"criterion_text":"-Adequate baseline organ function, evidenced by the following laboratory results within 3 weeks of randomization: - 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 MDRD formula or CKD-EPI formula or Cockcroft and Gault formula - SGOT (AST), SGPT (ALT) and alkaline phosphatase ≤ 2.5 × ULN"}
  • {"criterion_text":"-For men participating in the trial: • As fertility may be affected permanently with protocol treatment, we advise offering to patient sperm preservation prior to treatment. • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive** method that together result in a failure rate of <1% per year during the treatment period and for 6 months after the last dose of chemotherapies or 3 months and half (14 weeks) after the last dose of palbociclib. Men must refrain from donating sperm during the same period. • With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of chemotherapies or 3 months and half (14 weeks) after last dose of palbociclib to avoid exposing the embryo. ** For female partner, a highly effective method of birth control includes: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence"}
  • {"criterion_text":"-Signed, written informed consent."}
  • {"criterion_text":"-Histologically confirmed ER+ (at least 10 % of cells staining positive for ER), HER-2 negative, early invasive breast cancer based on results of local pathology. Testing may be performed on diagnostic core biopsy or resection specimen."}
  • {"criterion_text":"-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."}

Exclusion criteria

  • {"criterion_text":"-Evidence of macroscopic distant metastases, investigated according to local institutional guidelines"}
  • {"criterion_text":"-Concomitant anticancer treatment with the exception of bone antiresorptive agents or LHRH agonists in male patients treated with an aromatase-inhibitor"}
  • {"criterion_text":"-History of allergic reactions attributed to compounds of chemical or biological composition similar to palbociclib or to chemotherapy components"}
  • {"criterion_text":"-Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption"}
  • {"criterion_text":"-Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization"}
  • {"criterion_text":"-Patients who received treatment with live vaccines within 30 days prior the first dose of study medication."}
  • {"criterion_text":"-History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis."}
  • {"criterion_text":"-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. Note: For patients for whom doxorubicin or epirubicin is planned, an adequate baseline cardiac function (left ventricular ejection fraction ≥ 50%) should have been proven no more than 1 year before treatment start."}
  • {"criterion_text":"-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"}
  • {"criterion_text":"-Other malignancy within the last 5 years except: adequately treated non-metastatic non-melanoma skin cancer, or successfully treated in situ carcionoma for example curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast."}
  • {"criterion_text":"-Previous history of invasive breast cancer"}
  • {"criterion_text":"-Systemic anticancer therapy prior to the breast cancer surgery"}
  • {"criterion_text":"-Prior therapy with any CDK4/6 inhibitor"}
  • {"criterion_text":"-Concurrent investigational agent within 28 days of randomization or five elimination half-lives, whichever is longer"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The primary endpoint in this study is the 3-year distant recurrence-free interval rate in the experimental arm.","definition_or_measurement_approach":"3-year distant recurrence-free interval (DRFI) rate measured in the experimental arm at 3 years after randomization."}

Secondary endpoints

  • {"endpoint_text":"-Distant recurrence-free interval at 3 years in the control arm.","definition_or_measurement_approach":"DRFI measured at 3 years in the control arm."}
  • {"endpoint_text":"-Breast cancer specific survival at 3 years in both arms.","definition_or_measurement_approach":"Breast cancer specific survival measured at 3 years in both arms."}
  • {"endpoint_text":"-Overall survival at 3 years in both arms.","definition_or_measurement_approach":"Overall survival measured at 3 years in both arms."}
  • {"endpoint_text":"-Adverse events according to CTCAE v5.0 recorded at every patient visit in both arms.","definition_or_measurement_approach":"Safety assessed by recording adverse events at each visit using CTCAE v5.0."}
  • {"endpoint_text":"-Treatment discontinuation and dose reduction rates in both arms.","definition_or_measurement_approach":"Rates of treatment discontinuation and dose reductions collected for both arms."}
  • {"endpoint_text":"-Reason for treatment discontinuation.","definition_or_measurement_approach":"Documented reasons for treatment discontinuation."}
  • {"endpoint_text":"-HRQoL questionnaires (modified QLQ-C30, ELD-14, and selected items from the BR45 module) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.","definition_or_measurement_approach":"Health-related quality of life assessed using modified QLQ-C30, ELD-14, and BR45 items at specified timepoints."}
  • {"endpoint_text":"-Geriatric assessment tools (G8, iADL, ADL, Gait speed, CCI, social situation) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.","definition_or_measurement_approach":"Geriatric assessments (G8, iADL, ADL, gait speed, Charlson Comorbidity Index, social situation) at specified timepoints."}

Recruitment

Planned Sample Size
347
Recruitment Window Months
84
Consent Approach
Signed, written informed consent is required from each participant. Participation in mandatory translational research requires explicit consent for sequential blood sampling. Subject information and consent form documents and addenda are available in multiple languages (English, French, German, Dutch, Italian, Spanish, Polish, Portuguese as evidenced by language-specific ICF documents). Consent is provided by the patient (no paediatric assent applicable).

Geography

Total Number Of Sites
49
Total Number Of Participants
347

Belgium

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
34
Number Of Sites
7
Number Of Participants
56

Sites

Site Name
Heilig-Hartziekenhuis Lier
Department Name
Medical Oncology
Principal Investigator Name
Annelies Troch
Principal Investigator Email
Annelies.Troch@hhzhlier.be
Contact Person Name
Annelies Troch
Contact Person Email
Annelies.Troch@hhzhlier.be
Site Name
Vitaz
Department Name
Medical Oncology
Principal Investigator Name
Els Everaert
Principal Investigator Email
dr.elseveraert@gmail.com
Contact Person Name
Els Everaert
Contact Person Email
dr.elseveraert@gmail.com
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Principal Investigator Name
Frank Cornelis
Principal Investigator Email
frank.cornelis@saintluc.uclouvain.be
Contact Person Name
Frank Cornelis
Site Name
UZ Leuven
Department Name
Medical Oncology
Principal Investigator Name
Hans Wildiers
Principal Investigator Email
hans.wildiers@uzleuven.be
Contact Person Name
Hans Wildiers
Contact Person Email
hans.wildiers@uzleuven.be
Site Name
CHU De Liege
Department Name
Medical Oncology
Principal Investigator Name
Elodie Gonne
Principal Investigator Email
egonne@chuliege.be
Contact Person Name
Elodie Gonne
Contact Person Email
egonne@chuliege.be
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
christof.vulsteke@azmmsj.be
Contact Person Name
Christof Vulsteke
Contact Person Email
christof.vulsteke@azmmsj.be
Site Name
Institut Jules Bordet
Department Name
Medical Oncology
Principal Investigator Name
Michail Ignatiadis
Principal Investigator Email
michail.ignatiadis@hubruxelles.be
Contact Person Name
Michail Ignatiadis

France

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
13-03-2024
Processing Time Days
54
Number Of Sites
12
Number Of Participants
164

Sites

Site Name
Centre Francois Baclesse
Department Name
Medical Oncology
Principal Investigator Name
Christelle Levy
Principal Investigator Email
c.levy@baclesse.fr
Contact Person Name
Christelle Levy
Contact Person Email
c.levy@baclesse.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Principal Investigator Name
Mony Ung
Principal Investigator Email
ung.mony@iuct-oncopole.fr
Contact Person Name
Mony Ung
Contact Person Email
ung.mony@iuct-oncopole.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Catherine Terret
Principal Investigator Email
catherine.terret@lyon.unicancer.fr
Contact Person Name
Catherine Terret
Site Name
Institut Curie
Department Name
Medical Oncology
Principal Investigator Name
Etienne Brain
Principal Investigator Email
etienne.brain@curie.fr
Contact Person Name
Etienne Brain
Contact Person Email
etienne.brain@curie.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Medical Oncology
Principal Investigator Name
Frank Priou
Principal Investigator Email
frank.priou@chd-vendee.fr
Contact Person Name
Frank Priou
Contact Person Email
frank.priou@chd-vendee.fr
Site Name
Hospices Civils De Lyon
Department Name
Medical Oncology
Principal Investigator Name
Julien Peron
Principal Investigator Email
julien.peron@chu-lyon.fr
Contact Person Name
Julien Peron
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Principal Investigator Name
Audrey Mailliez
Principal Investigator Email
a-mailliez@o-lambret.fr
Contact Person Name
Audrey Mailliez
Contact Person Email
a-mailliez@o-lambret.fr
Site Name
Centre Henri Becquerel
Department Name
Medical Oncology
Principal Investigator Name
Olivier Rigal
Principal Investigator Email
olivier.rigal@chb.unicancer.fr
Contact Person Name
Olivier Rigal
Contact Person Email
olivier.rigal@chb.unicancer.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Medical Oncology
Principal Investigator Name
Laurence Venat-Bouvet
Principal Investigator Email
laurence.venat@chu-limoges.fr
Contact Person Name
Laurence Venat-Bouvet
Contact Person Email
laurence.venat@chu-limoges.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Clinical Oncology
Principal Investigator Name
Alain Lortholary
Principal Investigator Email
alain.lortholary@groupeconfluent.fr
Contact Person Name
Alain Lortholary
Site Name
Hospices Civils De Lyon (Pierre-Benite site)
Department Name
Medical Oncology
Principal Investigator Name
Julien Peron
Principal Investigator Email
julien.peron@chu-lyon.fr
Contact Person Name
Julien Peron
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Centre Jean Perrin
Department Name
Medical Oncology
Principal Investigator Name
Xavier Durando
Principal Investigator Email
xavier.durando@clermont.unicancer.fr
Contact Person Name
Xavier Durando

Germany

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
21-02-2024
Processing Time Days
33
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Kreiskrankenhaus Torgau Johann Kentmann gGmbH
Department Name
Oncology
Principal Investigator Name
Eike Simon
Principal Investigator Email
simon@kkh-torgau.de
Contact Person Name
Eike Simon
Contact Person Email
simon@kkh-torgau.de
Site Name
Marien Hospital Witten
Department Name
Oncology
Principal Investigator Name
Monika Graeser
Principal Investigator Email
monika.graeser@brustzentrum-rhein-ruhr.com
Contact Person Name
Monika Graeser
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Oncology
Principal Investigator Name
Sherko Kuemmel
Principal Investigator Email
s.kuemmel@kem-med.com
Contact Person Name
Sherko Kuemmel
Contact Person Email
s.kuemmel@kem-med.com
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Oncology
Principal Investigator Name
Joachim Rom
Principal Investigator Email
Joachim.rom@klinikumfrankfurt.de
Contact Person Name
Joachim Rom
Site Name
Studienzentrum Onkologie Ravensburg GmbH
Department Name
Oncology
Principal Investigator Name
Thomas Decker
Principal Investigator Email
thomas.decker@onkonet.eu
Contact Person Name
Thomas Decker
Contact Person Email
thomas.decker@onkonet.eu
Site Name
MKS St. Paulus GmbH
Department Name
Oncology
Principal Investigator Name
Sarah Wetzig
Principal Investigator Email
s.wetzig@marien-kh.de
Contact Person Name
Sarah Wetzig
Contact Person Email
s.wetzig@marien-kh.de

Italy

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
23-02-2024
Processing Time Days
35
Number Of Sites
9
Number Of Participants
28

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Department of Internal Medicine
Principal Investigator Name
Alberto Ballestrero
Principal Investigator Email
aballestrero@unige.it
Contact Person Name
Alberto Ballestrero
Contact Person Email
aballestrero@unige.it
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
Medical oncology
Principal Investigator Name
Alice Giacobino
Principal Investigator Email
alice.giacobino@aslbi.piemonte.it
Contact Person Name
Alice Giacobino
Site Name
AUSL Modena - Ospedale B. Ramazzini
Department Name
Medical oncology
Principal Investigator Name
Katia Cagossi
Principal Investigator Email
k.cagossi@ausl.mo.it
Contact Person Name
Katia Cagossi
Contact Person Email
k.cagossi@ausl.mo.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
oncology
Principal Investigator Name
Alessandra Beano
Principal Investigator Email
abeano@cittadellasalute.to.it
Contact Person Name
Alessandra Beano
Contact Person Email
abeano@cittadellasalute.to.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Medical oncology
Principal Investigator Name
Marina Elena Cazzaniga
Principal Investigator Email
marinaelena.cazzaniga@irccs-sangerardo.it
Contact Person Name
Marina Elena Cazzaniga
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncology
Principal Investigator Name
Filippo Giovanardi
Principal Investigator Email
filippo.giovanardi@ausl.re.it
Contact Person Name
Filippo Giovanardi
Contact Person Email
filippo.giovanardi@ausl.re.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
oncology
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi
Site Name
Ospedale Mater Salutis Di Legnago
Department Name
Medical oncology
Principal Investigator Name
Filippo Greco
Principal Investigator Email
filippo.greco@aulss9.veneto.it
Contact Person Name
Filippo Greco
Contact Person Email
filippo.greco@aulss9.veneto.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Medical oncology
Principal Investigator Name
Lorenzo Gianni
Principal Investigator Email
lorenzo.gianni@auslromagna.it
Contact Person Name
Lorenzo Gianni
Contact Person Email
lorenzo.gianni@auslromagna.it

Portugal

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
66
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Champalimaud Clinical Centre
Department Name
Breast Cancer Unit
Principal Investigator Name
Berta Sousa
Principal Investigator Email
berta.sousa@fundacaochampalimaud.pt
Contact Person Name
Berta Sousa
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical oncology
Principal Investigator Name
Ines Pousa
Principal Investigator Email
ines.pousa@ipoporto.min-saude.pt
Contact Person Name
Ines Pousa

Spain

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
62
Number Of Sites
12
Number Of Participants
60

Sites

Site Name
Salut Sant Joan De Reus
Department Name
Medical oncology
Principal Investigator Name
Maria Masvidal-Hernandez
Principal Investigator Email
maria.masvidal@salutsantjoan.cat
Contact Person Name
Maria Masvidal-Hernandez
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical oncology
Principal Investigator Name
Estela Vega
Principal Investigator Email
evega@hmhospitales.com
Contact Person Name
Estela Vega
Contact Person Email
evega@hmhospitales.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Miriam Arumi de Dios
Principal Investigator Email
marumi@vhio.net
Contact Person Name
Miriam Arumi de Dios
Contact Person Email
marumi@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical oncology
Principal Investigator Name
Javier Salvador Bofill
Principal Investigator Email
jsalvad2002@yahoo.es
Contact Person Name
Javier Salvador Bofill
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital Universitario Severo Ochoa
Department Name
Medical oncology
Principal Investigator Name
Maria Jose Echarri
Principal Investigator Email
mecharrigonzalez@yahoo.es
Contact Person Name
Maria Jose Echarri
Contact Person Email
mecharrigonzalez@yahoo.es
Site Name
MD Anderson Cancer Center (Spain)
Department Name
Medical oncology
Principal Investigator Name
Maria Isabel Calvo
Principal Investigator Email
micalvop@mdanderson.es
Contact Person Name
Maria Isabel Calvo
Contact Person Email
micalvop@mdanderson.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Medical oncology
Principal Investigator Name
Joaquin Gavila
Principal Investigator Email
jogagre@hotmail.com
Contact Person Name
Joaquin Gavila
Contact Person Email
jogagre@hotmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Maria Vidal
Principal Investigator Email
mjvidal@clinic.cat
Contact Person Name
Maria Vidal
Contact Person Email
mjvidal@clinic.cat
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Medical oncology
Principal Investigator Name
Juan Antonio Virizuela Echaburu
Principal Investigator Email
javirizuelae@seom.org
Contact Person Name
Juan Antonio Virizuela Echaburu
Contact Person Email
javirizuelae@seom.org
Site Name
Consorci Sanitari Del Maresme
Department Name
Medical oncology
Principal Investigator Name
Assumpcio Lopez Paradis
Principal Investigator Email
alopezpa@iconcologia.net
Contact Person Name
Assumpcio Lopez Paradis
Contact Person Email
alopezpa@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical oncology
Principal Investigator Name
Laura Lema
Principal Investigator Email
laura.lema@gmail.com
Contact Person Name
Laura Lema
Contact Person Email
laura.lema@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical oncology
Principal Investigator Name
Begona Bermejo
Principal Investigator Email
begobermejo@gmail.com
Contact Person Name
Begona Bermejo
Contact Person Email
begobermejo@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
25-02-2024
Processing Time Days
37
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Breast Cancer and Reconstructive Surgery Clinic
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
zbigniew.nowecki@nio.gov.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
zbigniew.nowecki@nio.gov.pl

Sponsor

Primary sponsor

Full Name
European Organisation For Research And Treatment Of Cancer
Organisation Type
Patient organisation/association
Country Of Registered Address
Belgium

Third parties

  • {"country":"Spain","full_name":"Solti Group","duties_or_roles":"Codes: 1; 15 (site activation, management and contracting)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"GBG Forschungs GmbH","duties_or_roles":"Codes: 1; 15 (site activation, management and contracting)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"Code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"UZ Leuven","duties_or_roles":"Code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Federation Nationale Des Centres De Lutte Contre Le Cancer","duties_or_roles":"Codes: 1; 15 (site activation, management and contracting)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Luxembourg","full_name":"Luxembourg Institute Of Health","duties_or_roles":"Code: 15 (Sample storage and shipment)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"ETOP IBCSG Partners Foundation","duties_or_roles":"Codes: 1; 15 (site activation, management and contracting)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
IBRANCE (palbociclib)
Active Substance
palbociclib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation (EU) (EU marketing authorisation numbers present in product records)
Dose Levels
75 mg | 100 mg | 125 mg
Combination Treatment
Yes

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