Clinical trial • Phase III • Oncology

PALBOCICLIB for Breast cancer

Phase III trial of PALBOCICLIB for Breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
07-11-2024

Trial design

Randomised, open-label, arm a: palbociclib (ibrance) plus anti-her2 therapy (e.g. trastuzumab/pertuzumab) plus endocrine therapy; arm b: anti-her2 therapy plus endocrine therapy. specific doses/schedules are not specified in the ctis record.-controlled Phase III trial in Spain, Italy, Portugal and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: palbociclib (IBRANCE) plus anti-HER2 therapy (e.g. trastuzumab/pertuzumab) plus endocrine therapy; Arm B: anti-HER2 therapy plus endocrine therapy. Specific doses/schedules are not specified in the CTIS record.
Target Sample Size
215

Eligibility

Recruits 215 No vulnerable populations selected. Participants must be ≥18 years (or per national guidelines). Signed Preliminary Screening Informed Consent Form and signed Main Informed Consent Form are required prior to any study-specific assessments and procedures. No assent procedures or minor/other vulnerable-population consent processes are described..

Pregnancy Exclusion
Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.
Vulnerable Population
No vulnerable populations selected. Participants must be ≥18 years (or per national guidelines). Signed Preliminary Screening Informed Consent Form and signed Main Informed Consent Form are required prior to any study-specific assessments and procedures. No assent procedures or minor/other vulnerable-population consent processes are described.

Inclusion criteria

  • {"criterion_text":"- Signed Preliminary Screening Informed Consent Form obtained prior to any study specific assessments and procedures"}
  • {"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":"- Serum or urine pregnancy test must be negative within 7 days of randomization in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential and male patients randomized into the study must use adequate contraception for the duration of protocol treatment which is for 6 months after the last treatment with palbociclib if they are in Arm A and for 7 months after last treatment with trastuzumab if in either Arm A or Arm B. Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository)."}
  • {"criterion_text":"- Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy regimen to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion) 12 weeks between last dose of chemotherapy–anti-HER2therapy and randomization are allowed. Endocrine therapy could start before study randomization."}
  • {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures"}
  • {"criterion_text":"- Prior Treatment Specifics: Patients may or may not have received neo/adjuvant therapy, but must have a disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis ≥6 months"}
  • {"criterion_text":"- Patients must have received an acceptable, standard, chemotherapy containing anti-HER2 based induction therapy for the treatment of metastatic breast cancer prior to study enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only for trastuzumab-based regimen). Eligible patients are expected to have completed 6 cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles of treatment is acceptable for patients experiencing significant toxicity associated with treatment as long as they are without evidence of disease progression (i.e. CR, PR or SD). The maximum number of cycles is 8. Patients can randomize immediately following completion of their induction therapy, or for those who have already completed induction, a gap of 12 weeks between their last infusion/dose of induction therapy and the C1D1 visit is permitted. Patients are eligible provided they are without evidence of disease progression by local assessment (i.e. CR, PR or SD)."}
  • {"criterion_text":"- Patients with a history or presence of asymptomatic CNS metastases are eligible provided they meet all of the following criteria: • Disease outside the CNS is present. • No evidence of interim progression between the completion of induction therapy and the screening radiographic study • No history of intracranial hemorrhage or spinal cord hemorrhage • Not requiring anti-convulsants for symptomatic control • Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement for corticosteroid"}
  • {"criterion_text":"- Baseline Body Function Specifics: Absolute neutrophil count ≥ 1,000/mm3"}
  • {"criterion_text":"- Platelets ≥ 100,000/mm3"}
  • {"criterion_text":"- Hemoglobin ≥ 10g/dL"}
  • {"criterion_text":"- Age ≥18 years (or per national guidelines)"}
  • {"criterion_text":"- Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert’s Syndrome."}
  • {"criterion_text":"- Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 × institutional ULN (≤5 x ULN if liver metastases are present)."}
  • {"criterion_text":"- Serum creatinine below the upper limit of normal (ULN) of the institutional normal range or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN"}
  • {"criterion_text":"- Left ventricular ejection fraction (LVEF)  50% at baseline as determined by either ECHO or MUGA"}
  • {"criterion_text":"- Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer."}
  • {"criterion_text":"- Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines."}
  • {"criterion_text":"- Patients must agree to provide a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity."}
  • {"criterion_text":"- Patients should be willing to provide a representative tumor specimen obtained from recently biopsied metastatic disease if clinically feasible. This is recommended but optional tissue."}
  • {"criterion_text":"- Randomization Screening: Signed Main Informed Consent Form obtained prior to any study specific assessments and procedures"}
  • {"criterion_text":"- Age ≥ 18 years (or per national guidelines)"}
  • {"criterion_text":"- ECOG performance status 0-1"}

Exclusion criteria

  • {"criterion_text":"- Concurrent therapy with other Investigational Products."}
  • {"criterion_text":"- Prior therapy with any CDK 4/6 inhibitor."}
  • {"criterion_text":"- History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib."}
  • {"criterion_text":"- Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for list of strong inhibitors or inducers of CYP3A isoenzymes)."}
  • {"criterion_text":"- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation."}
  • {"criterion_text":"- Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry."}
  • {"criterion_text":"- Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib."}
  • {"criterion_text":"- QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes."}
  • {"criterion_text":"- Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) as assessed by the Investigator","definition_or_measurement_approach":"PFS assessed by the Investigator (investigator-assessed progression-free survival)."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3-year and 5-year survival probabilities","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Objective response (OR: CR or PR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of CNS metastasis","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Safety: Type, incidence, severity (as graded by the NCI CTCAE v. 4.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities","definition_or_measurement_approach":"Safety assessed by recording AEs and lab abnormalities; severity graded by NCI CTCAE v4.0; attribution to study medication as appropriate."}
  • {"endpoint_text":"- Patient Reported Outcomes: Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status","definition_or_measurement_approach":"PROs assessed using FACT-B TOI-PFB instrument and other HRQOL measures as specified."}

Recruitment

Planned Sample Size
215
Recruitment Window Months
109
Consent Approach
Participants must provide a signed Preliminary Screening Informed Consent Form prior to any study-specific assessments and procedures and a signed Main Informed Consent Form prior to randomization and study-specific procedures. Participants must be aged ≥18 years (or per national guidelines). ICFs and participant information documents are available in country-specific versions (documents present for Spain, Italy, Portugal, Germany, France) and language-specific materials (e.g. Spanish, Italian, Portuguese, German, French) are provided as indicated in the CTIS documents.

Geography

Total Number Of Sites
60
Total Number Of Participants
303

Spain

Latest Decision Or Authorization Date
11-08-2025
Number Of Sites
17
Number Of Participants
113

Sites

Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Susana De la Cruz Sánchez
Contact Person Email
na@na.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Pilar Cantizani Maillo
Contact Person Email
na@na.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Aleix Prat Aparicio
Contact Person Email
na@na.com
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Contact Person Name
Cesar A. Rodriguez Sanchez
Contact Person Email
na@na.com
Site Name
Salut Sant Joan De Reus
Department Name
Oncology
Contact Person Name
Cinta Albacar
Contact Person Email
na@na.com
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Fandiño
Contact Person Name
Miguel Quintela
Contact Person Email
na@na.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Eva Ciruelos
Contact Person Email
na@na.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Pilar Sánchez Henarejos
Contact Person Email
na@na.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Sonia Pernas
Contact Person Email
na@na.com
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Oncology
Contact Person Name
Juan Antonio Virizuela
Contact Person Email
na@na.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Santiago Escribá
Contact Person Email
na@na.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Manuel Ruíz Borrego
Contact Person Email
na@na.com
Site Name
Hospital Universitari General De Catalunya
Department Name
Oncology
Contact Person Name
Xavier González Farré
Contact Person Email
na@na.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo
Contact Person Email
na@na.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Pilar Zamora Auñón
Contact Person Email
na@na.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Yann Izarzugaza Perón
Contact Person Email
na@na.com
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Raúl Márquez
Contact Person Email
na@na.com

Italy

Latest Decision Or Authorization Date
06-08-2025
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
SDD - Medical Oncology
Contact Person Name
Claudio Zamagni
Contact Person Email
czamagni@aosp.bo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Medical Oncology
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Medical Oncology
Contact Person Name
Claudia Andreetta
Site Name
University Hospital Of Ferrara
Department Name
Medical Oncology
Contact Person Name
Alessio Schirone
Contact Person Email
a.frassoldati@ospfe.it

Portugal

Latest Decision Or Authorization Date
05-08-2025
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Hospital Beatriz Angelo
Department Name
Oncology
Contact Person Name
Mafalda Casa-Nova
Contact Person Email
na@na.com
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Cláudia Vieira
Contact Person Email
na@na.com
Site Name
Champalimaud Clinical Centre
Department Name
Oncology
Contact Person Name
Berta Sousa
Contact Person Email
na@na.com
Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Contact Person Name
Mónica Nave
Contact Person Email
na@na.com

France

Latest Decision Or Authorization Date
06-08-2025
Number Of Sites
25
Number Of Participants
129

Sites

Site Name
Institut Godinot
Department Name
Oncologue
Contact Person Name
Christelle JOUANNAUD
Site Name
Institut Bergonie
Department Name
Oncologue
Contact Person Name
Nathalie QUENEL-TUEUX
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Oncologue
Contact Person Name
Julien GRENIER
Contact Person Email
j.grenier@isc84.org
Site Name
Centre Jean Perrin
Department Name
Oncologue
Contact Person Name
Marie Ange MOURET REYNIER
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologue
Contact Person Name
Claudia LEFEUVRE PLESSE
Contact Person Email
c.lefeuvre@rennes.unicancer.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologue
Contact Person Name
Philippe FOLLANA
Site Name
Institut Curie
Department Name
Oncologue
Contact Person Name
Delphine LOIRAT
Contact Person Email
delphine.loirat@curie.fr
Site Name
Centre azureen de cancerologie
Department Name
Oncologue
Contact Person Name
Rémy LARGILLIER
Contact Person Email
R.Largillier@cac-mougins.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologue
Contact Person Name
Paule AUGEREAU
Site Name
Oncopole Claudius Regaud
Department Name
Oncologue
Contact Person Name
Florence DALENC
Site Name
Centre Oscar Lambret
Department Name
Oncologue
Contact Person Name
Emilie KACZMAREK
Contact Person Email
e-kaczmarek@o-lambret.fr
Site Name
Centre Hospitalier De Cholet
Department Name
Oncologue
Contact Person Name
Victor SIMMET
Contact Person Email
victor.simmet@ch-cholet.fr
Site Name
Institut Curie (Paris)
Department Name
Oncologue
Contact Person Name
Delphine LOIRAT
Contact Person Email
delphine.loirat@curie.fr
Site Name
Centre Henri Becquerel
Department Name
Oncologue
Contact Person Name
Florian CLATOT
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologue
Contact Person Name
Audrey HENNEQUIN
Contact Person Email
ahennequin@cgfl.fr
Site Name
Hopital Tenon
Department Name
Oncologue
Contact Person Name
Joseph GLIGOROV
Contact Person Email
joseph.gligorov@aphp.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologue
Contact Person Name
D'HONDT Véronique
Site Name
Centre Paul Strauss
Department Name
Oncologue
Contact Person Name
Thierry PETIT
Contact Person Email
t.petit@icans.eu
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Oncologue
Contact Person Name
Gilles FREYER
Site Name
Institut Gustave Roussy
Department Name
Oncologue
Contact Person Name
Barbara PISTILLI
Site Name
Institut Paoli Calmettes
Department Name
Oncologue
Contact Person Name
Renaud SABATIER
Contact Person Email
SABATIERR@ipc.unicancer.fr
Site Name
Centre Francois Baclesse
Department Name
Oncologue
Contact Person Name
Christelle LEVY
Contact Person Email
c.levy@baclesse.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Oncologue
Contact Person Name
Pierre HEUDEL
Site Name
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Department Name
Oncologue
Contact Person Name
Anne-Claire HARDY-BESSARD
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologue
Contact Person Name
Laurence VENAT BOUVET
Contact Person Email
laurence.venat@chu-limoges.fr

Germany

Latest Decision Or Authorization Date
23-02-2026
Number Of Sites
10
Number Of Participants
34

Sites

Site Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Department Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Contact Person Name
Raquel von Schumann
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Klinische Studien
Contact Person Name
Claudia Schumacher
Site Name
Klinikum Bayreuth GmbH
Department Name
Frauenklinik
Contact Person Name
Christoph Mundhenke
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Marion van Mackelenbergh
Site Name
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Department Name
Frauenklinik
Contact Person Name
Michael Schrauder
Contact Person Email
mschrauder@leopoldina.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Senologie an der Klinik für Frauenheilkunde und Geburtshilfe des Universitätsklinikums Münster
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Breast unit
Contact Person Name
Jennifer Spönlein
Contact Person Email
j.spoenlein@kem-med.com
Site Name
DIAKOVERE Krankenhaus gGmbH
Department Name
Frauenklinik
Contact Person Name
Kristina Lübbe
Contact Person Email
kristina.luebbe@diakovere.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Frauenheilkunde
Contact Person Name
Beate Rautenberg

Sponsor

Primary sponsor

Full Name
Alliance Foundation Trials LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"United States","full_name":"Pfizer, INC.","duties_or_roles":"Source of monetary support / funding","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IBRANCE 125 mg hard capsules
Active Substance
PALBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation holder listed (EU/1/16/1147/006)
Dose Levels
125 mg (maxDailyDoseAmount 125 mg indicated in CTIS record)
Maximum Dose
125 mg
Investigational Product Name
IBRANCE 75 mg hard capsules
Active Substance
PALBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation holder listed (EU/1/16/1147/002)
Dose Levels
75 mg (maxDailyDoseAmount 75 mg indicated in CTIS record)
Maximum Dose
75 mg
Investigational Product Name
IBRANCE 100 mg hard capsules
Active Substance
PALBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation holder listed (EU/1/16/1147/004)
Dose Levels
100 mg (maxDailyDoseAmount 100 mg indicated in CTIS record)
Maximum Dose
100 mg
Combination Treatment
Yes

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