Clinical trial • Phase II/III • Oncology

(R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE for HER2-positive breast cancer | Brain metastases

Phase II/III trial of (R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLI…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive breast cancer | Brain metastases
Trial Stage
Phase II/III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-12-2025
First CTIS Authorization Date
28-04-2026

Trial design

Randomised, open-label, tucatinib in combination with trastuzumab and capecitabine versus ro7771950 in combination with trastuzumab and capecitabine; dosing/schedule not specified in the available data-controlled, adaptive Phase II/III trial across 110 sites in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Tucatinib in combination with trastuzumab and capecitabine versus RO7771950 in combination with trastuzumab and capecitabine; dosing/schedule not specified in the available data
Adaptive
True, described as a two-part, seamless, adaptive Phase II/III design; no detailed adaptive rules (e.g., interim analysis timing, stopping rules, dose-escalation rules) are provided in the available data
Target Sample Size
413

Eligibility

Recruits 413 isVulnerablePopulationSelected = true. Subject information and informed consent documents include infant authorization forms (e.g. "L1_SIS and ICF Infant Authorization Form") and other ICF variants (pregnant partner, PPA, localized versions). Documents indicate arrangements to obtain authorization/consent for infants and special subject groups, but specific assent/guardian procedures are not detailed in the available data..

Vulnerable Population
isVulnerablePopulationSelected = true. Subject information and informed consent documents include infant authorization forms (e.g. "L1_SIS and ICF Infant Authorization Form") and other ICF variants (pregnant partner, PPA, localized versions). Documents indicate arrangements to obtain authorization/consent for infants and special subject groups, but specific assent/guardian procedures are not detailed in the available data.

Inclusion criteria

  • {"criterion_text":"- Pathologically documented breast cancer that is locally advanced inoperable (LAI) or metastatic breast cancer (MBC)"}
  • {"criterion_text":"- Confirmed HER2-positive status, as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines, by central laboratory testing of formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample. HER2-positive status will be defined as 3+ by IHC and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies"}
  • {"criterion_text":"- Stage 1 participants: Measurable disease only, assessable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and/or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Stage 2 participants: Measurable or non-measurable disease assessable by RECIST v1.1 and/or RANO-BM For both stages: Lytic or mixed lytic bone lesions that can be assessed by computed tomography (CT), magnetic resonance imaging (MRI), or X-ray can be accepted as measurable disease in the absence of other measurable lesions."}
  • {"criterion_text":"- Participants must have received at least one prior line of anti-HER2-based therapy for LAI or metastatic disease"}
  • {"criterion_text":"- Participants must have received prior treatment with an anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), administered in the neoadjuvant, adjuvant, or metastatic setting. However, participants for whom prior ADC therapy was not appropriate (e.g., due to lack of access or being medically unfit) may be considered for enrollment."}
  • {"criterion_text":"- Prior treatment with a tyrosine kinase inhibitor (TKI) in the neoadjuvant/adjuvant setting is acceptable, provided that the interval between the completion of TKI treatment and development of locally advanced inoperable (LAI) or metastatic disease is > 12 months. Prior treatment with TKIs for LAI/metastatic breast cancer (MBC) is not permitted."}

Exclusion criteria

  • {"criterion_text":"- Treatment with investigational therapy within 28 days prior to initiation of study treatment"}
  • {"criterion_text":"- Concurrent anti-cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions (i.e., hormone replacement therapy for hypothyroidism) or for ovarian function suppression is allowed. Ongoing or planned bisphosphonate treatment is allowed in participants with bone metastases."}
  • {"criterion_text":"- Based on screening brain MRI, any of the following criteria for participants with brain metastasis: – Progressive neurologic impairment or increased intracranial pressure, which is symptomatic (including nausea, vomiting, blurred vision, headache, epilepsy, etc.) – Any intracranial lesion that is expected to require immediate local therapy. After local therapy, the participant can be re-screened for the protocol. – Requirement for systemic corticosteroids for management of CNS symptoms at a total daily dose of 2 mg of dexamethasone (or equivalent). A stable or tapering dose of 2 mg is permitted. – Requirement for anti-epileptic medication for seizure control, with the exception of stable-dose levetiracetam"}
  • {"criterion_text":"- Participants who meet one of the following cardiac criteria: – Congestive heart failure (CHF; New York Heart Association [NYHA] functional classification) of 2 – Clinically significant peripheral arterial disease, like coronary artery disease, hypertrophic cardiomyopathy, or dilated cardiomyopathy – Abnormalities in the ECG measurements: such as first-degree heart block, second degree heart block, third-degree heart block, prolonged PR interval: 0.20 s – Any clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention – Unstable angina – Myocardial infarction within the past 6 months – Percutaneous transluminal coronary angioplasty/stenting, coronary artery bypass graft within 6 months of the first dose of the study treatment – QT interval corrected through use of Fridericia's formula (QTcF) prolongation (470 ms for women and 450 ms for men), a known history of QTcF prolongation or Torsade de Pointes; or is on drugs that are required for existing medical conditions and that may result in QT prolongation (e.g., anti-arrhythmic drugs) – Poorly controlled hypertension (e.g., systolic  180 mm Hg or diastolic  100 mmHg) – History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy) – Coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing) – Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome"}
  • {"criterion_text":"- Participants with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Participants with a diagnosis of hepatitis B or C that has been treated and cleared (viral genetic test should fulfil the local laboratory definition for \"cleared\"), and normal liver function are eligible to participate in the study if the other eligibility parameters are met. Virologic testing should be conducted according to local institutional practices"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival in Full Analysis Set (PFS-FAS)","definition_or_measurement_approach":"Progression-free survival in the full analysis set (PFS-FAS). Measured as PFS (time to progression or death) in the full analysis set; disease measurability/assessments use RECIST v1.1 and/or RANO-BM as described for staging."}

Secondary endpoints

  • {"endpoint_text":"- Progression-Free Survival in participants with CNS metastases (PFS-CNS)","definition_or_measurement_approach":"PFS in participants with CNS metastases (PFS-CNS)."}
  • {"endpoint_text":"- Overall Survival in Full Analysis Set (OS-FAS)","definition_or_measurement_approach":"Overall survival measured in the full analysis set (OS-FAS)."}
  • {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Objective response rate assessed per tumor response criteria (e.g., RECIST v1.1 and/or RANO-BM where applicable)."}
  • {"endpoint_text":"- Duration Of Response (DOR)","definition_or_measurement_approach":"Duration of response (DOR) for responders."}
  • {"endpoint_text":"- Clinical Benefit Rate (CBR)","definition_or_measurement_approach":"Clinical benefit rate (CBR)."}
  • {"endpoint_text":"- Objective Response Rate in participants with CNS metastases (ORR-CNS)","definition_or_measurement_approach":"ORR assessed specifically in participants with CNS metastases."}
  • {"endpoint_text":"- Duration Of Response in participants with CNS metastases (DOR-CNS)","definition_or_measurement_approach":"DOR assessed in participants with CNS metastases."}
  • {"endpoint_text":"- Clinical Benefit Rate in participants with CNS metastases (CBR-CNS)","definition_or_measurement_approach":"CBR assessed in participants with CNS metastases."}
  • {"endpoint_text":"- Mean and mean changes from baseline score in symptoms experienced by participants with brain tumors, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasm module (EORTC QLQ-BN20)","definition_or_measurement_approach":"Patient-reported symptom scores using EORTC QLQ-BN20; mean and mean change from baseline by cycle and treatment arm."}
  • {"endpoint_text":"- Mean and mean changes from baseline score in function (role, physical, cognitive, social, emotional) and HRQoL by cycle and between treatment arms as measured by the EORTC QLQ-C30","definition_or_measurement_approach":"Patient-reported functioning and HRQoL via EORTC QLQ-C30; mean and mean change from baseline by cycle and arm."}
  • {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Safety assessed by incidence and severity of AEs graded using NCI CTCAE v5.0."}
  • {"endpoint_text":"- Change from baseline in selected clinical laboratory test results, vital signs, echocardiogram/multiple-gated acquisition (ECHO/MUGA), Electrocardiogram (ECG), and Columbia Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Clinical safety measures including lab tests, vitals, ECHO/MUGA, ECG, and C-SSRS changes from baseline."}
  • {"endpoint_text":"- Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities (i.e., PPE, mouth/throat sores, nausea, vomiting, diarrhea, headache, rash, abdominal pain, decreased appetite, fatigue) as assessed through use of the patient-reported outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)","definition_or_measurement_approach":"Patient-reported symptomatic toxicities assessed via PRO-CTCAE (presence, frequency, severity, interference with daily activities)."}
  • {"endpoint_text":"- Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item Functional Assessment of Cancer Therapy (FACT-GP5)","definition_or_measurement_approach":"Proportion reporting each FACT-GP5 response option by timepoint and arm."}
  • {"endpoint_text":"- Change from baseline/worsening in symptomatic treatment toxicities (PRO-CTCAE) and treatment side-effect bother FACT-GP5","definition_or_measurement_approach":"Change from baseline/worsening assessed via PRO-CTCAE and FACT-GP5."}
  • {"endpoint_text":"- Health utility scores of the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)","definition_or_measurement_approach":"Health utility measured with EQ-5D-5L; utility scores derived for economic modelling."}
  • {"endpoint_text":"- Plasma concentration of RO7771950 and its metabolite(s) at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic plasma concentrations of RO7771950 and metabolite(s) at specified timepoints."}

Recruitment

Registry Or Advocacy Recruitment
True; organisations present in the trial third-party list include patient organisations/associations: European Organisation For Research And Treatment Of Cancer | Stichting EuroQol Research Foundation | Asociatia Oncohelp
Digital Remote Recruitment
True; a social media recruitment post is present (document "K2_Social Media Post_WO46069"); specifics of digital/remote screening or e-consent are not detailed
Planned Sample Size
413
Recruitment Window Months
45
Consent Approach
Informed consent is managed via subject information and informed consent form (ICF) documents listed for publication (multiple L1/L2 variants). Infant Authorization Forms and localized ICFs (EN, FR, NL, PT, CZ, RO and others) are present. Specific assent/guardian consent procedures are referenced by the availability of infant authorization and pregnant partner ICF documents, but detailed procedures and wording are not available in the provided data.

Methods

  • Recruitment arrangements documents submitted (K1_RecruitmentArrangements) for multiple countries (documents present in CTIS document list)
  • Use of social media recruitment (document titled "K2_Social Media Post_WO46069" listed among recruitment documents)
  • Site-based recruitment through participating hospitals/oncology centres in each member state (site lists provided per country)

Geography

Total Number Of Sites
110
Total Number Of Participants
413

Austria

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
36
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Internal Medicine I - Medical Oncology and Haematology
Principal Investigator Name
Clemens Dormann
Principal Investigator Email
studien.bhs@ordensklinikum.at
Contact Person Name
Clemens Dormann
Contact Person Email
studien.bhs@ordensklinikum.at
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine I
Principal Investigator Name
Rupert Bartsch
Principal Investigator Email
sekretariat_onko@meduniwien.ac.at
Contact Person Name
Rupert Bartsch
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
University Clinic for Internal Medicine III
Principal Investigator Name
Simon Gampenrieder
Principal Investigator Email
CRCS-M3_CTC@salk.at
Contact Person Name
Simon Gampenrieder
Contact Person Email
CRCS-M3_CTC@salk.at
Site Name
Medical University Of Graz
Department Name
Department of Clinical Oncology
Principal Investigator Name
Gabriel Rinnerthaler
Principal Investigator Email
onkologie@medunigraz.at
Contact Person Name
Gabriel Rinnerthaler
Contact Person Email
onkologie@medunigraz.at

Belgium

Earliest CTIS Part Ii Submission Date
08-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
20
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Medical Oncology
Principal Investigator Name
Marianne Hanssens
Principal Investigator Email
marianne.hanssens@azgroeninge.be
Contact Person Name
Marianne Hanssens
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Principal Investigator Name
François Duhoux
Principal Investigator Email
francois.duhoux@uclouvain.be
Contact Person Name
François Duhoux
Contact Person Email
francois.duhoux@uclouvain.be
Site Name
UZ Leuven
Department Name
Oncology
Principal Investigator Name
Françoise Derouane
Principal Investigator Email
trialunit@uzleuven.be
Contact Person Name
Françoise Derouane
Contact Person Email
trialunit@uzleuven.be
Site Name
Jessa Ziekenhuis
Department Name
Oncology
Principal Investigator Name
Annelies Requilé
Principal Investigator Email
annelies.requile@jessazh.be
Contact Person Name
Annelies Requilé
Contact Person Email
annelies.requile@jessazh.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Medical Oncology
Principal Investigator Name
Kevin Punie
Principal Investigator Email
aor@zas.be
Contact Person Name
Kevin Punie
Contact Person Email
aor@zas.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Donatienne Taylor
Principal Investigator Email
donatienne.taylor@chuuclnamur.uclouvain.be
Contact Person Name
Donatienne Taylor
Site Name
Emmaues
Department Name
Gynaeco-Oncology
Principal Investigator Name
Patrick Berteloot
Principal Investigator Email
patrick.berteloot@emmaus.be
Contact Person Name
Patrick Berteloot
Contact Person Email
patrick.berteloot@emmaus.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Andrea Gombos
Principal Investigator Email
andrea.gombos@hubruxelles.be
Contact Person Name
Andrea Gombos
Contact Person Email
andrea.gombos@hubruxelles.be

Czechia

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
41
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Principal Investigator Name
Karina Oršulová
Principal Investigator Email
karina.orsulova@mou.cz
Contact Person Name
Karina Oršulová
Contact Person Email
karina.orsulova@mou.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Principal Investigator Name
Vlastimila Čmejlová
Principal Investigator Email
vlastimila.cmejlova@fnmotol.cz
Contact Person Name
Vlastimila Čmejlová
Contact Person Email
vlastimila.cmejlova@fnmotol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Principal Investigator Name
Adam Paulík
Principal Investigator Email
adam.paulik@fnhk.cz
Contact Person Name
Adam Paulík
Contact Person Email
adam.paulik@fnhk.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Komplexní onkologické centrum, oddělení onkologie a radioterapie
Principal Investigator Name
Monika Mudráková
Principal Investigator Email
monika.mudrakova@nnj.agel.cz
Contact Person Name
Monika Mudráková
Contact Person Email
monika.mudrakova@nnj.agel.cz

France

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
82
Number Of Sites
14
Number Of Participants
24

Sites

Site Name
Institut Curie
Department Name
Oncologie médicale
Principal Investigator Name
Francois-Clément Bidard
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
Francois-Clément Bidard
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie
Principal Investigator Name
Caroline Bailleux
Principal Investigator Email
caroline.bailleux@nice.unicancer.fr
Contact Person Name
Caroline Bailleux
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie médicale
Principal Investigator Name
Nicolas Isambert
Principal Investigator Email
Nicolas.ISAMBERT@chu-poitiers.fr
Contact Person Name
Nicolas Isambert
Site Name
Centre Leon Berard
Department Name
Oncologie médicale
Principal Investigator Name
Louis Larrouquere
Principal Investigator Email
louis.larrouquere@lyon.unicancer.fr
Contact Person Name
Louis Larrouquere
Site Name
Institut Curie (Paris)
Department Name
Oncologie médicale
Principal Investigator Name
Francois-Clément Bidard
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
Francois-Clément Bidard
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie
Principal Investigator Name
Florence Dalenc
Principal Investigator Email
Dalenc.Florence@iuct-oncopole.fr
Contact Person Name
Florence Dalenc
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie
Principal Investigator Name
Fanny Le Du
Principal Investigator Email
f.ledu@rennes.unicancer.fr
Contact Person Name
Fanny Le Du
Contact Person Email
f.ledu@rennes.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Principal Investigator Name
Alessandro Viansone
Principal Investigator Email
Alessandro.VIANSONE@gustaveroussy.fr
Contact Person Name
Alessandro Viansone
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie
Principal Investigator Name
Mario Campone
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Institut Bergonie
Department Name
Oncologie
Principal Investigator Name
Camille Chakiba
Principal Investigator Email
camille.chakiba@gmail.com
Contact Person Name
Camille Chakiba
Contact Person Email
camille.chakiba@gmail.com
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie
Principal Investigator Name
William Jacot
Principal Investigator Email
william.jacot@icm.unicancer.fr
Contact Person Name
William Jacot
Contact Person Email
william.jacot@icm.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain)
Department Name
Oncologie médicale
Principal Investigator Name
Mario Campone
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Oncologie
Principal Investigator Name
Alexandre Tassin De Nonneville
Principal Investigator Email
tassindenonnevillea@ipc.unicancer.fr
Contact Person Name
Alexandre Tassin De Nonneville
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Oncologie
Principal Investigator Name
Coralie Frenoux
Principal Investigator Email
cfrenoux@chu-grenoble.fr
Contact Person Name
Coralie Frenoux
Contact Person Email
cfrenoux@chu-grenoble.fr

Germany

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
34
Number Of Sites
17
Number Of Participants
40

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik f. Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Stephan Seitz
Principal Investigator Email
sseitz@csj.de
Contact Person Name
Stephan Seitz
Contact Person Email
sseitz@csj.de
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Claus Hanusch
Principal Investigator Email
claus.hanusch@swmbrk.de
Contact Person Name
Claus Hanusch
Contact Person Email
claus.hanusch@swmbrk.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Theresa Link
Principal Investigator Email
Studiensekretariat.gyn@ukdd.de
Contact Person Name
Theresa Link
Contact Person Email
Studiensekretariat.gyn@ukdd.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Studienzentrum Brustzentrum im BHH
Principal Investigator Name
Vera Seidel-Eider
Principal Investigator Email
vera.seidel@charite.de
Contact Person Name
Vera Seidel-Eider
Contact Person Email
vera.seidel@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Sabine Heublein
Principal Investigator Email
studienzentrale.ufk@uniklinik-ulm.de
Contact Person Name
Sabine Heublein
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
breast unit
Principal Investigator Name
Jennifer Spönlerin
Principal Investigator Email
s.spoenlein@kem-med.com
Contact Person Name
Jennifer Spönlerin
Contact Person Email
s.spoenlein@kem-med.com
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Department Name
N.A.
Principal Investigator Name
Andreas Köhler
Principal Investigator Email
studien@onkologie-langen.de
Contact Person Name
Andreas Köhler
Contact Person Email
studien@onkologie-langen.de
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
N.A.
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
weide@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
weide@invo-koblenz.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Gynäkologische Studienzentrale
Principal Investigator Name
Volkmar Müller
Principal Investigator Email
v.mueller@uke.de
Contact Person Name
Volkmar Müller
Contact Person Email
v.mueller@uke.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Marion Tina van Mackelenbergh
Principal Investigator Email
SGO@uksh.de
Contact Person Name
Marion Tina van Mackelenbergh
Contact Person Email
SGO@uksh.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Gynäkologische Onkologie
Principal Investigator Name
Carlo Fremd
Principal Investigator Email
carlo.fremd@med.uni-heidelberg.de
Contact Person Name
Carlo Fremd
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Frauenklinik
Principal Investigator Name
Michael Patrick Lux
Principal Investigator Email
M.Lux@vincenz.de
Contact Person Name
Michael Patrick Lux
Contact Person Email
M.Lux@vincenz.de
Site Name
Medizinische Hochschule Hannover
Department Name
Zentrum für Frauenheilkunde, Gynäkologische Onkologie
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
park-simon.tjoung-won@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
St. Elisabethgruppe katholische Kliniken Rhein Ruhr GmbH, Betriebsstätte Marien Hospital
Department Name
N.A.
Principal Investigator Name
Monika Graeser
Principal Investigator Email
Monika.Graeser@elisabethgruppe.de
Contact Person Name
Monika Graeser
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
N.A.
Principal Investigator Name
Vesna Bjelic-Radisic
Principal Investigator Email
Vesna.bjelic-radisic@helios-gesundheit.de
Contact Person Name
Vesna Bjelic-Radisic
Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
N.A.
Principal Investigator Name
Athina Kostara
Principal Investigator Email
info@gynonco.de
Contact Person Name
Athina Kostara
Contact Person Email
info@gynonco.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe, Brustzentrum Sektion Senologie
Principal Investigator Name
Joke Tio
Principal Investigator Email
joke.tio@ukmuenster.de
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de

Hungary

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
32
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiológiai osztály
Principal Investigator Name
Edina Mészáros
Principal Investigator Email
m.edina@uzsoki.hu
Contact Person Name
Edina Mészáros
Contact Person Email
m.edina@uzsoki.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Principal Investigator Name
Zsolt Horváth
Principal Investigator Email
horvathzso.study@kmk.hu
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
Semmelweis Egyetem
Department Name
Belgyógyászati és Onkológiai Klinika
Principal Investigator Name
Gyöngyvér Szentmártoni
Principal Investigator Email
gyszentmartoni@gmail.com
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Gyógyszerterápiás Kp, Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai O. "Kemoterápia B"
Principal Investigator Name
Magdolna Dank
Principal Investigator Email
dank.magdolna@oncol.hu
Contact Person Name
Magdolna Dank
Contact Person Email
dank.magdolna@oncol.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Pándy Kálmán Tagkórház - Onkológiai Osztály
Principal Investigator Name
László Torday
Principal Investigator Email
laszlo.torday@gmail.com
Contact Person Name
László Torday
Contact Person Email
laszlo.torday@gmail.com
Site Name
University Of Debrecen
Department Name
Onkológiai Klinika
Principal Investigator Name
Péter Árkosy
Principal Investigator Email
arkosy.peter@med.unideb.hu
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu

Italy

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
33
Number Of Sites
16
Number Of Participants
37

Sites

Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Fabio Puglisi
Principal Investigator Email
fabio.puglisi@cro.it
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Alberto Zambelli
Principal Investigator Email
azambelli@asst-pg23.it
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Giampaolo Bianchini
Principal Investigator Email
bianchini.giampaolo@hsr.it
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Oncologia
Principal Investigator Name
Federico Piacentini
Principal Investigator Email
federico.piacentini@unimore.it
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Oncologia Medica
Principal Investigator Name
Benedetta Pellegrino
Principal Investigator Email
benedetta.pellegrino@unipr.it
Contact Person Name
Benedetta Pellegrino
Contact Person Email
benedetta.pellegrino@unipr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOSD Medicina di precisione in senologia
Principal Investigator Name
Alessandra Fabi
Principal Investigator Email
alessandra.fabi@policlinicogemelli.it
Contact Person Name
Alessandra Fabi
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia
Principal Investigator Name
Maria Vita Sanò
Principal Investigator Email
mariavita.sano@humanitascatania.it
Contact Person Name
Maria Vita Sanò
Site Name
Humanitas Mirasole S.p.A.
Department Name
Breast Oncology Unit
Principal Investigator Name
Carmen Criscitiello
Principal Investigator Email
carmen.criscitiello@hunimed.eu
Contact Person Name
Carmen Criscitiello
Contact Person Email
carmen.criscitiello@hunimed.eu
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Principal Investigator Name
Claudio Vernieri
Principal Investigator Email
claudio.vernieri@istitutotumori.mi.it
Contact Person Name
Claudio Vernieri
Site Name
Istituto Oncologico Veneto
Department Name
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Antonino Musolino
Principal Investigator Email
antonino.musolino@irst.emr.it
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Senologia Medica
Principal Investigator Name
Marco Angelo Colleoni
Principal Investigator Email
marco.colleoni@ieo.it
Contact Person Name
Marco Angelo Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Rebecca Pedersini
Principal Investigator Email
rebecca.pedersini@gmail.com
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Oncologia Falck
Principal Investigator Name
Alberto Giuseppe Agostara
Contact Person Name
Alberto Giuseppe Agostara
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Oncologia Clinica Sperimentale di Senologia
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
m.delaurentiis@istitutotumori.na.it
Contact Person Name
Michelino De Laurentiis
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
Oncologia Medica
Principal Investigator Name
Francesco Pantano
Principal Investigator Email
f.pantano@policlinicocampus.it
Contact Person Name
Francesco Pantano
Contact Person Email
f.pantano@policlinicocampus.it

Portugal

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
60
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Maria Castro Henriques
Principal Investigator Email
maria.castro.henriques@ulsge.min-saude.pt
Contact Person Name
Maria Castro Henriques
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Hugo Nunes
Principal Investigator Email
hnunes@ipolisboa.min-saude.pt
Contact Person Name
Hugo Nunes
Contact Person Email
hnunes@ipolisboa.min-saude.pt
Site Name
Hospital Da Luz S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
Jorge Correia
Contact Person Name
Jorge Correia
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Luís Costa
Principal Investigator Email
luis.costa@ulssm.min-saude.pt
Contact Person Name
Luís Costa
Contact Person Email
luis.costa@ulssm.min-saude.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Centro de Investigação e Inovação
Principal Investigator Name
Mafalda Casa-Nova
Contact Person Name
Mafalda Casa-Nova
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Serviço de Oncologia
Principal Investigator Name
Marta Vilaça
Principal Investigator Email
investigacao@ulsm.min-saude.pt
Contact Person Name
Marta Vilaça
Contact Person Email
investigacao@ulsm.min-saude.pt
Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Oncologia
Principal Investigator Name
Marina Vitorino
Principal Investigator Email
uic@hff.min-saude.pt
Contact Person Name
Marina Vitorino
Contact Person Email
uic@hff.min-saude.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Joana Bordalo e Sá
Principal Investigator Email
clinicalstudies@ipoporto.min-saude.pt
Contact Person Name
Joana Bordalo e Sá

Romania

Earliest CTIS Part Ii Submission Date
20-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
14
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncologie medicala
Principal Investigator Name
Laurentia Gales
Principal Investigator Email
secretariat@iob.ro
Contact Person Name
Laurentia Gales
Contact Person Email
secretariat@iob.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie medicala
Principal Investigator Name
Nicoleta Antone
Principal Investigator Email
office@iocn.ro
Contact Person Name
Nicoleta Antone
Contact Person Email
office@iocn.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (second listing)
Department Name
Oncologie medicala
Principal Investigator Name
Raluca Mihaila
Principal Investigator Email
secretariat@iob.ro
Contact Person Name
Raluca Mihaila
Contact Person Email
secretariat@iob.ro
Site Name
Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati
Department Name
Oncologie medicala
Principal Investigator Name
Marius Paduraru
Principal Investigator Email
secretariatscjugalati@gmail.com
Contact Person Name
Marius Paduraru
Site Name
Spital Judetean De Urgenta Satu Mare
Department Name
Oncologie medicala
Principal Investigator Name
Dan Luchian
Principal Investigator Email
office@sjusm.ro
Contact Person Name
Dan Luchian
Contact Person Email
office@sjusm.ro
Site Name
Asociatia Oncohelp
Department Name
Oncologie medicala
Principal Investigator Name
Cristina Oprean
Principal Investigator Email
office@oncohelp.ro
Contact Person Name
Cristina Oprean
Contact Person Email
office@oncohelp.ro

Spain

Earliest CTIS Part Ii Submission Date
20-01-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
104
Number Of Sites
16
Number Of Participants
34

Sites

Site Name
Hospital Universitario De Canarias
Department Name
Oncología
Principal Investigator Name
Josefina Cruz Jurado
Principal Investigator Email
jcruzjurado@gmail.com
Contact Person Name
Josefina Cruz Jurado
Contact Person Email
jcruzjurado@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología
Principal Investigator Name
Francisco de Asis Ayala de la Peña
Principal Investigator Email
franciscoasis.ayala@salud.madrid.org
Contact Person Name
Francisco de Asis Ayala de la Peña
Site Name
Hospital Universitario Basurto
Department Name
Oncología
Principal Investigator Name
Elena Galve Calvo
Principal Investigator Email
ELENA.GALVECALVO@osakidetza.eus
Contact Person Name
Elena Galve Calvo
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncología
Principal Investigator Name
Maria Isabel Blancas Lopez-Barajas
Principal Investigator Email
iblancas@ugr.es
Contact Person Name
Maria Isabel Blancas Lopez-Barajas
Contact Person Email
iblancas@ugr.es
Site Name
Hospital Beata Maria Ana
Department Name
Oncología
Principal Investigator Name
Javier Cortés Castán
Principal Investigator Email
javier.cortes@maj3.health
Contact Person Name
Javier Cortés Castán
Contact Person Email
javier.cortes@maj3.health
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Principal Investigator Name
Maria Gion Cortés
Principal Investigator Email
mariagion@gmail.com
Contact Person Name
Maria Gion Cortés
Contact Person Email
mariagion@gmail.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncología
Principal Investigator Name
Jose Manuel Perez Garcia
Principal Investigator Email
josemanuel.perez@quironsalud.es
Contact Person Name
Jose Manuel Perez Garcia
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncología
Principal Investigator Name
Angel Guerrero Zotano
Principal Investigator Email
angel.guerrero.zotano@gmail.com
Contact Person Name
Angel Guerrero Zotano
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncología
Principal Investigator Name
Jose Luis Alonso Romero
Principal Investigator Email
josel.alonso2@carm.es
Contact Person Name
Jose Luis Alonso Romero
Contact Person Email
josel.alonso2@carm.es
Site Name
Hospital Universitario De Jaen
Department Name
Oncología
Principal Investigator Name
Alicia Cano Jimenez
Principal Investigator Email
aliciacanojimenez@gmail.com
Contact Person Name
Alicia Cano Jimenez
Contact Person Email
aliciacanojimenez@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncología
Principal Investigator Name
Emilia Dominguez Recio
Principal Investigator Email
emilia.dominguez.recio@gmail.com
Contact Person Name
Emilia Dominguez Recio
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Manuel Alva Bianchi
Principal Investigator Email
malvabianchi@gmail.com
Contact Person Name
Manuel Alva Bianchi
Contact Person Email
malvabianchi@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncología
Principal Investigator Name
Tomas Pascual Martinez
Principal Investigator Email
topascual@clinic.cat
Contact Person Name
Tomas Pascual Martinez
Contact Person Email
topascual@clinic.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología
Principal Investigator Name
Manuel Ruiz Borrego
Principal Investigator Email
ruizsabater@gmail.com
Contact Person Name
Manuel Ruiz Borrego
Contact Person Email
ruizsabater@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncología
Principal Investigator Name
Sonia Pernas Simón
Principal Investigator Email
spernas@iconcologia.net
Contact Person Name
Sonia Pernas Simón
Contact Person Email
spernas@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Santiago Escrivá de Romaní
Principal Investigator Email
sescriva@vhio.net
Contact Person Name
Santiago Escrivá de Romaní
Contact Person Email
sescriva@vhio.net

Poland

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
38
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Centrum Onkologii
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
onko.cwbk@iczmp.edu.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
onko.cwbk@iczmp.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Onkologii
Principal Investigator Name
Piotr Wysocki
Principal Investigator Email
klinikaonkologii@su.krakow.pl
Contact Person Name
Piotr Wysocki
Contact Person Email
klinikaonkologii@su.krakow.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział dzienny Onkologii Klinicznej – Breast Unit
Principal Investigator Name
Małgorzata Pieniążek
Principal Investigator Email
onkocwbk@dcopih.pl
Contact Person Name
Małgorzata Pieniążek
Contact Person Email
onkocwbk@dcopih.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Jacek Kabut
Principal Investigator Email
patrycja.tylec@sum.edu.pl
Contact Person Name
Jacek Kabut
Contact Person Email
patrycja.tylec@sum.edu.pl
Site Name
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Principal Investigator Name
Magdalena Ciążyńska
Principal Investigator Email
chemioterapia.tomaszow@affidea.com
Contact Person Name
Magdalena Ciążyńska
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Elżbieta Senkus‑Konefka
Principal Investigator Email
bkonko@uck.gda.pl
Contact Person Name
Elżbieta Senkus‑Konefka
Contact Person Email
bkonko@uck.gda.pl
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii I Immunoonkologii z Oddziałem Dziennym Terapii Onkologicznej
Principal Investigator Name
Tomasz Lewandowski
Principal Investigator Email
clinicalsoffice@poliklinika.net
Contact Person Name
Tomasz Lewandowski
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Chemioterapii
Principal Investigator Name
Rodryg Ramlau
Principal Investigator Email
katedraonkologii@ump.edu.pl
Contact Person Name
Rodryg Ramlau
Contact Person Email
katedraonkologii@ump.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Klinika Onkologii Klinicznej z Pododdziałem Onkologii Ginekologicznej
Principal Investigator Name
Małgorzata Drzymała
Principal Investigator Email
badania.kliniczne.onko@szpital.rzeszow.pl
Contact Person Name
Małgorzata Drzymała
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Principal Investigator Name
Barbara Radecka
Principal Investigator Email
badaniakliniczne@onkologia.opole.pl
Contact Person Name
Barbara Radecka

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
4g Clinical LLC
Responsibilities
IxRS Provider
Name
PPD Global Limited
Responsibilities
Study Management Provider

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS Provider","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central Imaging Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Study Management Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"(RFMH) Research Foundation for Mental Hygiene, Inc","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Health care"}
  • {"country":"Netherlands","full_name":"Stichting EuroQol Research Foundation","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Patient organisation/association"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory (duty code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"European Organisation For Research And Treatment Of Cancer","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Patient organisation/association"}

Investigational products

Investigational Product Name
RO7771950
Active Substance
(R)-N-(4-([1,2,4]-TRIAZOLO[1,5-C]-PYRIMIDIN-7-YLOXY)-3-METHYLPHENYL)-5-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-6-METHOXYQUINAZOLIN-4-AMINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
TUCATINIB
Active Substance
TUCATINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
600 mg (max daily amount listed in product entry)
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
TRASTUZUMAB
Active Substance
TRASTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION or SUBCUTANEOUS USE
Route
IV INFUSION / SUBCUTANEOUS
Combination Treatment
Yes

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