Clinical trial • Phase III • Oncology

TRASTUZUMAB, PERTUZUMAB for Breast cancer|HER2-positive breast cancer

Phase III trial of TRASTUZUMAB, PERTUZUMAB for Breast cancer|HER2-positive breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer|HER2-positive breast cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|ADC|Small molecule

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
21-11-2024

Trial design

Randomised, open-label, three randomized arms described: arm a (trastuzumab + pertuzumab + carboplatin auc2 iv day 1 & day 8 q3w + paclitaxel 90 mg/m2 iv day 1 & day 8 q3w for 6 cycles; or protocol v3.0 ph fdc sc: initial 1,200 mg pertuzumab/600 mg trastuzumab + hyaluronidase then 600 mg/600 mg q3w), arm b1 (anthracycline: adriamycin 60 mg/m2 iv q3w or epirubicin 90 mg/m2 iv q3w + cyclophosphamide 600 mg/m2 iv q3w + atezolizumab 1200 mg iv q3w for 3 cycles, followed by trastuzumab + pertuzumab + carboplatin auc2 + paclitaxel 90 mg/m2 + atezolizumab 1200 mg iv q3w), arm b2 (trastuzumab + pertuzumab + carboplatin auc2 + paclitaxel 90 mg/m2 + atezolizumab 1200 mg iv q3w for 6 cycles; protocol v3.0 option to use ph fdc sc dosing where applicable).-controlled Phase III trial across 59 sites in Austria, Romania, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Three randomized arms described: Arm A (Trastuzumab + Pertuzumab + Carboplatin AUC2 IV day 1 & day 8 q3w + Paclitaxel 90 mg/m2 IV day 1 & day 8 q3w for 6 cycles; or Protocol V3.0 PH FDC SC: initial 1,200 mg pertuzumab/600 mg trastuzumab + hyaluronidase then 600 mg/600 mg q3w), Arm B1 (Anthracycline: Adriamycin 60 mg/m2 IV q3w or Epirubicin 90 mg/m2 IV q3w + Cyclophosphamide 600 mg/m2 IV q3w + Atezolizumab 1200 mg IV q3w for 3 cycles, followed by Trastuzumab + Pertuzumab + Carboplatin AUC2 + Paclitaxel 90 mg/m2 + Atezolizumab 1200 mg IV q3w), Arm B2 (Trastuzumab + Pertuzumab + Carboplatin AUC2 + Paclitaxel 90 mg/m2 + Atezolizumab 1200 mg IV q3w for 6 cycles; Protocol V3.0 option to use PH FDC SC dosing where applicable).
Target Sample Size
646
Trial Duration For Participant
1825

Eligibility

Recruits 646 Vulnerable population selected (flag true). Only adults (≥18) are eligible. Written informed consent must be obtained prior to any study-specific screening procedures; subject information sheets and informed consent forms (country-specific ICFs and addenda) are provided. No provisions for assent (no minors included)..

Pregnancy Exclusion
Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle
Vulnerable Population
Vulnerable population selected (flag true). Only adults (≥18) are eligible. Written informed consent must be obtained prior to any study-specific screening procedures; subject information sheets and informed consent forms (country-specific ICFs and addenda) are provided. No provisions for assent (no minors included).

Inclusion criteria

  • {"criterion_text":"- Female patients aged 18 years or older with early high-risk ((T1cN1; T2N1; T3N0) or locally advanced and inflammatory breast cancers (stage III A-C according to AJCC) suitable for neoadjuvant treatment"}
  • {"criterion_text":"- Willing and able to comply with the protocol"}
  • {"criterion_text":"- Histologically confirmed unilateral invasive breast cancer"}
  • {"criterion_text":"- HER2 positive disease according to ASCO/CAP current guidelines"}
  • {"criterion_text":"- Known estrogen (ER) and progesterone receptor (PgR)"}
  • {"criterion_text":"- Availability of a representative paraffin-embedded (FFPE) tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, for assessment of ER, PgR, Ki67 and PD-L1 expression and for biomarker evaluation is mandatory"}
  • {"criterion_text":"- Consent to the collection of blood samples mandatorily before starting neoadjuvant treatment, after the first cycle of therapy, at the end of neoadjuvant treatment (before surgery), 6 months after surgery and at the end of all treatments."}
  • {"criterion_text":"- ECOG performance status 0 or 1"}
  • {"criterion_text":"- For women who are not postmenopausal (≥ 12 months of non-therapyinduced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization (not acceptable in Germany), hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices"}
  • {"criterion_text":"- Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures"}

Exclusion criteria

  • {"criterion_text":"- Evidence of bilateral breast cancer or metastatic disease (M1)"}
  • {"criterion_text":"- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins or hyaluronidase; only for patients enrolled in Germany: history of severe allergic reactions to any protocol anticancer agent or any of the excipients"}
  • {"criterion_text":"- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation"}
  • {"criterion_text":"- Patients with prior allogeneic stem cell or solid organ transplantation"}
  • {"criterion_text":"- History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, GuillainBarré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix A for preexisting autoimmune diseases and immune deficiencies)"}
  • {"criterion_text":"- History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan"}
  • {"criterion_text":"- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease"}
  • {"criterion_text":"- History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antibody [anti-HBc] test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA Only for patients enrolled in Germany: all patients have to undergo hepatitis and HIV testing during screening in order to adequately determine the infection status and ensure that patients with an active infection will be excluded from the trial."}
  • {"criterion_text":"- Active tuberculosis"}
  • {"criterion_text":"- Severe infections within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to Day 1"}
  • {"criterion_text":"- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1"}
  • {"criterion_text":"- Patients with HER2-negative defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by either In Situ Hybridization (ISH) or other amplification tests done locally are considered not eligible for the study"}
  • {"criterion_text":"- Other serious illness or medical condition, including but not limited to history of documented congestive cardiac failure; New York Heart Association (NYHA) Class II or greater CHF; angina pectoris requiring anti-anginal medication or unstable angina within 6 months prior to Day 1; evidence of transmural infarction on ECG; myocardial infarction stroke or transient ischemic attack (TIA) within 6 months prior to Day 1; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias; severe dyspnea at rest requiring supplementary oxygen therapy; uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected calcium > ULN)"}
  • {"criterion_text":"- Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs"}
  • {"criterion_text":"- Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus"}
  • {"criterion_text":"- Any of the following abnormal baseline hematological values: a. White blood count (WBC) < 2.5 x 109 /L b. Absolute Neutrophil Count (ANC) < 1.5 × 109 /L c. Lymphocyte count < 0.5 x 109 /L d. Platelet count < 100 × 109 /L e. Hemoglobin (Hb) < 10 g/dL"}
  • {"criterion_text":"- Any of the following abnormal baseline laboratory tests a. Serum total bilirubin > 1.5 × ULN (upper limit of normal) (except for patients with clearly documented Gilbert’s syndrome) b. Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 × ULN c. Alkaline phosphatase > 2.5× ULN d. Serum creatinine > 1.5 × ULN e. INR and aPTT > 1.5 × ULN within 2 weeks prior to enrollment. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose"}
  • {"criterion_text":"- Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multi-gated scintigraphic scan (MUGA)"}
  • {"criterion_text":"- Major surgical procedure within 28 days prior to Day 1 or anticipation of need for a major surgical procedure during the course of the study"}
  • {"criterion_text":"- Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Day 1 or at any time during the study; only for patients enrolled in Germany: the concomitant administration of yellow-fever vaccine is not allowed."}
  • {"criterion_text":"- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies"}
  • {"criterion_text":"- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment"}
  • {"criterion_text":"- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle"}
  • {"criterion_text":"- Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception as mentioned at point 8. of inclusion criteria"}
  • {"criterion_text":"- Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy; only for patients enrolled in Germany: presence of bleeding tumors."}
  • {"criterion_text":"- Previous investigational treatment for any condition other than malignancy within 4 weeks of randomization date; only for patients enrolled in Germany: or within 5 half-lives, whichever is longer."}
  • {"criterion_text":"- Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study"}
  • {"criterion_text":"- Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are eligible"}
  • {"criterion_text":"- Pre-existing motor or sensory neuropathy of grade > 1 for any reason"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event Free Survival (EFS)","definition_or_measurement_approach":"Primary objective: Compare 5-year Event-Free Survival (EFS) between Arm B (B1+B2) and Arm A; EFS measured over a 5-year period as per main objective."}

Secondary endpoints

  • {"endpoint_text":"- Pathological Complete Response (pCR)","definition_or_measurement_approach":"pCR defined as absence of invasive cells in breast and nodes (ypT0/is and ypN0) at surgery."}
  • {"endpoint_text":"- Relationship between pCR and EFS","definition_or_measurement_approach":"Correlation analysis comparing pCR status with Event-Free Survival (EFS) outcomes."}
  • {"endpoint_text":"- Clinical Overall Response (cOR) at the end of neo-adjuvant treatment","definition_or_measurement_approach":"Clinical overall response assessed at end of neoadjuvant therapy (per protocol-defined radiological/clinical response criteria)."}
  • {"endpoint_text":"- Disease-Free Survival (DFS)","definition_or_measurement_approach":"DFS measured from the time of surgery as specified in secondary objectives."}
  • {"endpoint_text":"- Distant Event Free Survival","definition_or_measurement_approach":"Distant EFS measured from the time of randomization as specified in secondary objectives."}
  • {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":"Overall survival measured from the time of randomization."}

Other endpoints

  • {"endpoint_text":"- Evaluate tolerability of the treatment regimens in the different study arms","definition_or_measurement_approach":"Safety and tolerability assessed by adverse event reporting and tolerability measures as per protocol."}
  • {"endpoint_text":"- Composition and specificity of the immune infiltrate of the tumor and of draining lymph nodes","definition_or_measurement_approach":"Immunological analyses on tumor and draining lymph node tissue to characterise immune infiltrate composition and specificity."}
  • {"endpoint_text":"- Conduct molecular and clinical analyses to assess the presence of predictive markers of benefit or resistance to the study regimens","definition_or_measurement_approach":"Molecular and clinical biomarker analyses on collected tissue and blood samples to identify predictive markers of response or resistance."}

Recruitment

Registry Or Advocacy Recruitment
True - Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Planned Sample Size
646
Recruitment Window Months
99
Consent Approach
Written informed consent obtained prior to any study-specific screening procedures; consent provided by the adult participant (female ≥18). Subject information sheets and ICFs (main ICF and addenda) are provided; country-specific ICF documents are available (e.g., versions for Austria/Germany - German, Italy - Italian, Spain - Spanish, Belgium - French/Dutch, Romania - local language, and English-language protocol synopsis/files). No assent procedures (minors not eligible).

Geography

Total Number Of Sites
59
Total Number Of Participants
646

Austria

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
536
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical University Of Vienna
Department Name
Frauenheilkunde, Klin. Abteilung für Allg. Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Christian Singer
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Klinische Abteilung für Innere Medizin 1
Contact Person Name
Petra Pichler

Romania

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
539
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Radiotherapy Clinical Department II
Contact Person Name
Rodica Anghel
Contact Person Email
rodicamanghel@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Radiotherapy I
Contact Person Name
Nicolata Antone
Contact Person Email
office@iocn.ro

Germany

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
536
Number Of Sites
12
Number Of Participants
65

Sites

Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Gynäkologie und Geburtshilfe
Contact Person Name
Oliver Tomé
Contact Person Email
oliver.tome@vincentius-ka.de
Site Name
St Johannes Hospital gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Georg Kunz
Contact Person Email
georg.kunz@joho-dortmund.de
Site Name
Marienhospital Bottrop gGmbH
Department Name
Gynäkologische Onkologie
Contact Person Name
Hans-Christian Kolberg
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
MVZ Onko Medical GmbH
Department Name
Gynäkologisch-Onkologische Praxis
Contact Person Name
Hans-Joachim Lück
Contact Person Email
hlueck@goph.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
St. Elisabeth Gruppe - Katholische Kliniken Rhein-Ruhr Marien Hospital Witten
Department Name
Brustzentrum Witten
Contact Person Name
Monika Graeser
Site Name
Klinikum Magdeburg gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Christoph Kahl
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Brustzentrum Ostthüringen
Contact Person Name
Dirk-Michael Zahm
Contact Person Email
dirk-michael.zahm@srh.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Gynäkologische Onkologie
Contact Person Name
Andreas Schneeweiss
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Gynäkologie
Contact Person Name
Susanne Barrot
Contact Person Email
susanne.barrot@uk-halle.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Achim Rody
Contact Person Email
achim.rody@uksh.de

Spain

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
539
Number Of Sites
23
Number Of Participants
222

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Contact Person Name
Veronica Conde Herrero
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Contact Person Name
Isabel Manuela Alvarez Lopez
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Montserrat Muñoz Mateu
Contact Person Email
mmunoz@clinic.cat
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Raquel Andres Conejero
Contact Person Email
umac.hcu@salud.aragon.es
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Sonia Servitja Tormo
Contact Person Email
sservitja@parcdesalutmar.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Yann Izarzugaza Peron
Contact Person Email
ceic@fjd.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Tamara Diaz Redondo
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Oncology
Contact Person Name
Elena Garcia Martinez
Contact Person Email
helenagarciam@gmail.com
Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Contact Person Name
Santiago Gonzalez Santiago
Contact Person Email
ucancer.hspa@salud-juntaex.es
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Laura García Estevez
Contact Person Email
lgestevez@mdanderson.es
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Contact Person Name
Cesar Rodriguez Sanchez
Contact Person Email
unidad_eecc@usal.es
Site Name
Hospital Universitario De Toledo
Department Name
Oncology
Contact Person Name
Juan David Cardenas
Contact Person Email
juandacardenas@hotmail.com
Site Name
Hospital Universitario Basurto
Department Name
Oncology
Contact Person Name
Elena Galve Clavo
Site Name
Fundacion Onkologikoa Fundazioa
Department Name
Oncology
Contact Person Name
Ander Urruticoechea Ribate
Contact Person Email
ensayos@onkologikoa.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Yolanda Jerez Gilarranz
Contact Person Email
yolanda.jerez@salud.madrid.org
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Contact Person Name
Rafael Lopez Lopez
Contact Person Email
rafael.lopez.lopez@sergas.es
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Oncology
Contact Person Name
Diego Malon Gimenez
Contact Person Email
bnasarre@ext.cnio.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Marta Andres Granyo
Contact Person Email
oncologia@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
José Ángel García Sáenz
Contact Person Email
jgsaenz@salud.madrid.org
Site Name
Hospital Virgen De Los Lirios
Department Name
Oncology
Contact Person Name
Amparo Oltra Ferrando
Contact Person Email
oncologia_d15@gva.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo De Las Heras
Contact Person Email
begobermejo@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
534
Number Of Sites
17
Number Of Participants
313

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Medical Oncology 1
Contact Person Name
Carmelo Bengala
Site Name
Azienda Sanitaria Locale Br
Department Name
Medical Oncology
Contact Person Name
Saverio Cinieri
Contact Person Email
saverio.cinieri@gmail.com
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Medical Oncology
Contact Person Name
Elena Poletto
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Medical Oncology
Contact Person Name
Claudio Dazzi
Contact Person Email
Claudio.dazzi@auslromagna.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Rimini)
Department Name
Medical Oncology
Contact Person Name
Lorenzo Gianni
Contact Person Email
lorenzo.gianni@auslromagna.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Struttura Semplice Sviluppo di Terapie Innovative
Contact Person Name
Del Mastro Lucia
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Department Name
Medical Oncology
Contact Person Name
Laura Deborah Locati
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Medical Oncology
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S. C. Medical Oncology 1
Contact Person Name
Gabriella Mariani
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Medical Oncology
Contact Person Name
Filippo Giovanardi
Contact Person Email
filippo.giovanardi@ausl.re.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Medical Oncology
Contact Person Name
Elena Rota Caremoli
Contact Person Email
ecrota@asst-pg23.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology (1Q-A)
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Medical Oncology
Contact Person Name
Stefania Gori
Contact Person Email
stefania.gori@sacrocuore.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Medical Oncology
Contact Person Name
Samanta Sarti
Contact Person Email
samanta.sarti@irst.emr.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
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology
Contact Person Name
Simona Gasparro
Contact Person Email
simona.gasparro@ifo.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Medical Oncology
Contact Person Name
Anna Gambaro
Contact Person Email
anna.gambaro@asst-fbf-sacco.it

Belgium

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
533
Number Of Sites
3
Number Of Participants
29

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Clinical Trial Oncology
Contact Person Name
Kevin PUNIE
Contact Person Email
kevin.punie@zas.be
Site Name
Antwerp University Hospital
Department Name
Clinical Trial Oncology
Contact Person Name
Sevilay Altintas
Contact Person Email
Sevilay.Altintas@uza.be
Site Name
Clinique Saint-Pierre
Department Name
Medical Oncology
Contact Person Name
Renaud Poncin

Sponsor

Primary sponsor

Full Name
Fondazione Michelangelo
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Contract research organisations

Name
P.R.I.S.M.A.-CRO Clinical Research Organisation GmbH
Responsibilities
Codes:1,12
Name
Optimapharm Research RO S.R.L.
Responsibilities
Codes:1,12
Name
Ad Hoc Clinical
Responsibilities
Codes:1,12

Third parties

  • {"country":"Italy","full_name":"Michelangelo Tech S.r.l.","duties_or_roles":"Codes:10,11,12,15 (agreements/contracts with sites and third parties; coordination with sites and third parties); code:9","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Optimapharm Research RO S.R.L.","duties_or_roles":"Codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"P.R.I.S.M.A.-CRO Clinical Research Organisation GmbH","duties_or_roles":"Codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Fundacion Grupo Espanol De Investigacion En Cancer De Mama","duties_or_roles":"Codes:1,12,2","organisation_type":"Patient organisation/association"}
  • {"country":"Italy","full_name":"Mediolanum Cardio Research S.r.l.","duties_or_roles":"Code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Istituto Europeo Di Oncologia S.r.l.","duties_or_roles":"Code:15 (PDL1 expression test, HER2, hormone receptor assay, Ki67 evaluation, Biobank.)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"Ad Hoc Clinical","duties_or_roles":"Codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"Codes:15 (IVRS30 - randomisation to treatment, database creation and electronic data collection form (eCRF)),6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"ICTA Project Management En Abrege ICTA P.M.","duties_or_roles":"Codes:1,12,15 (Local project management coordination)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Phesgo 1200 mg/600 mg solution for injection
Active Substance
TRASTUZUMAB, PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
Initial dose (PH FDC): 1,200 mg pertuzumab + 600 mg trastuzumab + 30,000 units hyaluronidase SC (per Protocol V3.0); maintenance 600 mg pertuzumab + 600 mg trastuzumab SC q3w
Dose Levels
Initial 1,200 mg pertuzumab/600 mg trastuzumab then 600 mg/600 mg q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
Max daily dose amount: 1200 mg (as recorded)
Investigational Product Name
Perjeta 420 mg concentrate for solution for infusion
Active Substance
PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
Loading dose 840 mg IV, then 420 mg IV q3w
Dose Levels
840 mg loading then 420 mg q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
Max daily dose amount: 840 mg (as recorded)
Investigational Product Name
Kadcyla 160 mg powder for concentrate for solution for infusion.
Active Substance
TRASTUZUMAB EMTANSINE
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
Trastuzumab emtansine 3.6 mg/kg IV q3w (adjuvant use for patients with residual invasive disease at surgery)
Dose Levels
3.6 mg/kg q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
Max daily dose amount recorded as 3 mg/kg (product data entry) but protocol adjuvant dosing specified as 3.6 mg/kg q3w
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
Atezolizumab 1200 mg IV infusion q3w
Dose Levels
1200 mg q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
Max daily dose amount: 1200 mg (as recorded)
Investigational Product Name
Phesgo 600 mg/600 mg solution for injection
Active Substance
TRASTUZUMAB, PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
Maintenance dose: 600 mg pertuzumab + 600 mg trastuzumab SC q3w (per product description/protocol)
Dose Levels
600 mg/600 mg q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
Max daily dose amount: 600 mg (as recorded)
Combination Treatment
Yes

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