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    Summary
    EudraCT Number:2022-002443-21
    Sponsor's Protocol Code Number:CO44195
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-002443-21
    A.3Full title of the trial
    A PHASE II, SINGLE-ARM STUDY OF GIREDESTRANT IN PATIENTS WITH GRADE 1 ENDOMETRIAL CANCER
    STUDIO A BRACCIO SINGOLO DI FASE II SU GIREDESTRANT IN PAZIENTI CON CARCINOMA DELL’ENDOMETRIO DI GRADO 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Giredestrant in Patients with Grade 1 Endometrial Cancer
    STUDIO SU GIREDESTRANT IN PAZIENTI CON CARCINOMA DELL'ENDOMETRIO DI GRADO 1
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCO44195
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel, Switzerland
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0000000
    B.5.5Fax number0000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGiredestrant
    D.3.2Product code [Ro 719-7597/F22]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO7197597
    D.3.9.4EV Substance CodeSUB216524
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Grade 1 Endometrial Cancer
    Carcinoma dell'endometrio di grado 1
    E.1.1.1Medical condition in easily understood language
    Grade 1 Endometrial Cancer is a type of cancer that begins in the uterus. It can happen before or after menopause and vaginal bleeding is the most frequent symptom.
    Il cancro dell'endometrio di grado 1 è un tipo di cancro che inizia nell'utero. Può accadere prima o dopo la menopausa e il sanguinamento vaginale è il sintomo più frequente.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014738
    E.1.2Term Endometrial cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To evaluate the efficacy of Giredestrant by regression rate by the Month 6 assessment
    -To evaluate the safety and tolerability of Giredestrant
    -Valutare l’efficacia di Giredestrant in base al tasso di regressione entro la valutazione del 6° mese
    -Valutare la sicurezza e la tollerabilità di Giredestrant
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of giredestrant by complete regression rate by the Month 6 assessment
    T-o evaluate the efficacy of giredestrant by duration of regression
    -To evaluate the efficacy of giredestrant by time to regression
    -To evaluate the efficacy of giredestrant by time to relapse or loss of clinical benefit
    -To characterize the giredestrant pharmacokinetic (PK) profile
    -Valutare l’efficacia di giredestrant in base al tasso di regressione completa entro la valutazione del 6°mese
    -Valutare l’efficacia di giredestrant in base alla durata della regressione
    -Valutare l’efficacia di giredestrant in base al tempo alla regressione
    -Valutare l’efficacia di giredestrant in base al tempo alla recidiva o alla perdita di beneficio clinico
    -Caraterizzare il profilo farmacocinetico (PK) di Giredestrant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age >= 18 years
    -Life expectancy >= 12 weeks
    -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    -Confirmed Grade 1 endometrial carcinoma (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D&C) sample must be provided within 2 months of enrollment to a central laboratory for histologic confirmation to determine eligibility
    -Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor
    -MRI or computed tomography (CT)-confirmation of no extrauterine disease
    -Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
    -No prior treatment for complex endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN), or endometrial cancer
    -Able and willing to take oral medications
    -Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    -Adequate hematologic and end-organ function
    -Negative human immunodeficiency virus (HIV) test at screening
    -For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 10 days after the final dose of giredestrant
    -Età >= 18 anni
    -Aspettativa di vita >= 12 settimane
    -Eastern Cooperative Oncology Group (ECOG) Performance Status di 0 o 1
    -Carcinoma endometriale (EC) di grado 1 confermato dall'istologia endometrioide per il quale i partecipanti sono disposti a ricevere 6 cicli di terapia in studio. De essere fornito o un campione di biopsia endometriale (EMB) o dilatazione e curettage (D& entro 2 mesi dall'arruolamento a un laboratorio centrale per la conferma istologica per determinare l'eligilità
    -Imaging di risonanza magnetica (MRI) - conferma di tumore non profondamente invasivo
    -MRI o tomografia computerizzata (TC) - conferma di assenza di malattia extrauterina
    -Disponibilità a sottoporsi a un minimo di 6 cicli continui di terapia prima della decisione dell'intervento chirurgico
    -Nessun trattamento precedente per iperplasia endometriale complessa (EH), neoplasia intraepiteliale endometriale (EIN) o il cancro dell'endometrio
    -Capacità e disponibilità ad assumere farmaci per via orale
    -Disponibilità e capacità di rispettare visite programmate, piani di trattamento, test di laboratorio e altre procedure di studio
    -Adeguata funzionalità ematologica e degli end-organ
    -Test negativo del virus dell'immunodeficienza umana (HIV) allo screening
    -Per le partecipanti di sesso femminile in età fertile: accettare di rimanere astinenti (astenersi da rapporti eterosessuali) o di usare la contraccezione e accettare di astenersi dal donare ovuli durante il periodo di trattamento e per 10 giorni dopo la dose finale di Giredestrant
    E.4Principal exclusion criteria
    -Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 10 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator’s choice of endocrine therapy
    -Participants with non-endometrioid histologies, such as serous, clear cell, and mixed
    -Treatment with investigational therapy within 28 days prior to initiation of study enrollment
    -Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6i, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
    -Any gastrointestinal condition causing malabsorption or obstruction
    -Has been on any hormonal treatment for complex atypical hyperplasia
    - Use hormone replacement therapy or/and phytoestrogen supplements or has been on progestin, tamoxifen or aromatase inhibitor within the prior 3 months
    -Known hypersensitivity to giredestrant or its excipients
    -Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
    -Evidence or high suspicion of metastatic/extrauterine disease at enrollment
    - Unwilling or unable to comply with study-related procedures, including all endometrial sampling/biopsies
    -Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 9 days after the completion of study treatment
    -Serious infections requiring IV antibiotics within 7 days prior to initiation of study treatment or any active infection
    -Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis, current alcohol abuse, cirrhosis, or positive test for viral hepatitis
    -Substance abuse within 12 months prior to screening
    -Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant’s safe participation in and completion of the study
    -History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death after curative treatment
    -Active tuberculosis
    -Significant cardiovascular disease
    -Participants with known coronary artery disease, congestive heart failure not meeting the above criterion or with a left ventricular ejection fraction 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
    -Major surgical procedure other than for diagnosis within 28 days prior to enrollment or anticipation of need for a major surgical procedure during the study
    -Prior allogeneic bone marrow transplantation or solid organ transplant
    -Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk for treatment complications Illnesses or conditions that interfere with the participant’s capacity to understand, follow, and/or comply with study procedures
    -Gravidanza o allattamento al seno o intenzione di rimanere incinta durante lo studio o entro 10 giorni dopo la dose finale di Gire o entro il periodo di tempo specificato dalle linee guida locali per la prescrizione dopo la dose finale della terapia endocrina scelta dallo sperimentatore
    -Partecipanti con istologie non endometrioidi, come sierose, cellule chiare e miste
    -Trattamento con terapia sperimentale entro 28 giorni prima dell'inizio dell'arruolamento allo studio
    -Trattamento per il cancro incluso, ma non limitato a chemioterapia, immunoterapia, chinasi ciclina-dipendente (CDK)4/6i, terapia endocrina, terapia biologica o terapia a base di erbe entro 28 giorni prima dell'inizio dell'arruolamento nello studio
    -Qualsiasi condizione gastrointestinale che causa malassorbimento o ostruzione
    -È stato sottoposto a qualsiasi trattamento ormonale per l'iperplasia atipica complessa
    -Uso della terapia ormonale sostitutiva o/e integratori di fitoestrogeni o è stato assunto progestinico, tamoxifene o inibitori dell'aromatasi nei 3 mesi precedenti
    -Ipersensibilità nota a giredestrant o ai suoi eccipienti
    -Malattia intercorrente nota o malattia psichiatrica/situazioni sociali che limiteranno la compliance con i requisiti di studio
    -Evidenza o alto sospetto di malattia metastatica/extrauterina al momento dell'arruolamento
    -Restio o incapace di rispettare le procedure relative allo studio, compresi tutti i prelievi/biopsie endometriali
    -Intervento chirurgico programmato, sia per il trattamento del cancro che per qualsiasi altro intervento chirurgico, durante il periodo di trattamento in studio e fino a 9 giorni dopo il completamento del trattamento in studio
    -Infezioni gravi che richiedono antibiotici per via endovenosa entro 7 giorni prima dell'inizio del trattamento in studio o qualsiasi infezione attiva
    -Partecipanti che hanno una malattia epatica clinicamente significativa compatibile con Child-Pugh Classe B o C, inclusa epatite attiva, abuso di alcol in corso, cirrosi o test positivo per l'epatite virale
    -Abuso di sostanze entro 12 mesi prima dello screening
    -Qualsiasi condizione medica grave o anomalia nei test clinici di laboratorio che precluda la partecipazione sicura del partecipante e il completamento dello studio
    -Storia di altri tumori maligni entro 5 anni prima dello screening, ad eccezione di quelli con un rischio trascurabile atteso di metastasi o morte dopo trattamento curativo
    -Tubercolosi attiva
    -Malattia cardiovascolare significativa
    -I partecipanti con malattia coronarica nota, insufficienza cardiaca congestizia che non soddisfa il criterio di cui sopra o con una frazione di eiezione ventricolare sinistra del 50% devono seguire un regime medico stabile ottimizzato secondo il parere del medico curante, in consultazione con un cardiologo, se appropriato
    -Intervento chirurgico maggiore diverso dalla diagnosi entro 28 giorni prima dell'arruolamento o anticipazione della necessità di un intervento chirurgico maggiore durante lo studio
    -Pregresso trapianto allogenico di midollo osseo o trapianto di organi solidi
    -Qualsiasi altra malattia, disfunzione metabolica, riscontro dell'esame obiettivo o riscontro clinico di laboratorio che dia un ragionevole sospetto di una malattia o condizione che controindica l'uso di un farmaco sperimentale o che può influenzare l'interpretazione dei risultati o rende il partecipante ad alto rischio di complicanze terapeutiche, Malattie o condizioni che interferiscono con la capacità del partecipante di comprendere, seguire e/o rispettare le procedure di studio
    E.5 End points
    E.5.1Primary end point(s)
    1. Regression rate by Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or have an increase in non-cancer/non-atypical hyperplasia (%) by the Month 6 assessment compared with baseline
    2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
    3. Change from baseline in targeted vital signs
    4. Change from baseline in targeted clinical laboratory test results
    1. Tasso di regressione per la valutazione al 6°mese, definito come partecipanti che hanno una diminuzione in percentuale del cancro o hanno un aumento dell'iperplasia non cancerosa/non atipica (%) entro la valutazione del 6°mese rispetto al basale
    2. Evento e gravità degli eventi avversi con gravità determinata secondo i criteri comuni di terminologia per gli eventi avversi (NCI CTCAE) v5.0 del National Cancer Institute
    3. Variazione rispetto al basale dei segni vitali specifici
    4. Variazione rispetto al basale nei risultati dei test clinici di laboratorio specifici
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline and Month 6
    2. Until 28 days after the final dose of study treatment
    3-4. From baseline at Screening visit, Day 1 of Cycles 1, 2, 3, Cycles 4 and Beyond
    1. Baseline and mese 6
    2. Fino al giorno 28 dopo la dose finale del trattamento di studio
    3-4. Dal baseline alla visita di screening, giorno 1 dei cicli 1, 2, 3, ciclo 4 e oltre
    E.5.2Secondary end point(s)
    1. Complete regression rate, defined as the participants who have an assessment of 100% of non-cancer/non-atypical hyperplasia by Month 6 assessment
    2. Duration of regression, defined as the time from the first regression to time of the first worsening
    3. Time to regression, defined as the time from the first study treatment to the first observation of EC regression
    4. Time to relapse or loss of clinical benefit per investigator, defined as the time from the first study treatment to relapse of the EC, or loss of clinical benefit per investigator, whichever occurs first. Participants will be censored if they have surgery at Month 6 and no relapse or loss of clinical benefit occurs before surgery
    5. Plasma concentration of giredestrant at specified timepoints
    1. tasso di regressione completa, da intendersi come partecipanti con valutazione di 100% di iperplasia non cancerosa/non atipica entro la valutazione del Mese 6
    2. Durata della regressione, da intedersi come il tempo dalla prima regressione al momento del primo peggioramento
    3. Tempo di regressione, da intendersi come il tempo dal primo trattamento in studio alla prima osservazione della regressione EC
    4. Tempo alla ricaduta o alla perdita del beneficio clinico per lo sperimentatore, da intendersi come il tempo dal primo trattamento in studio alla ricaduta della EC, o alla perdita del beneficio clinico per lo sperimentatore, a seconda dell'evento che si verifica per primo. I partecipanti saranno censurati se subiscono un intervento chirurgico al mese 6 e non si verifica alcuna ricaduta o perdita del beneficio clinico prima dell'intervento chirurgico
    5. Concentrazione plasmatica di giredestrant in punti temporali specificati
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Month 6
    2-4. Up to approximately 26 months
    5. At Day 1 of Cycles 1, 2, 3, 4, 6, and treatment discontinuation visit
    1. Al sesto mese
    2-4. Fino approssimativamente al mese 26
    5. al giorno 1 del ciclo 1, 2, 3, 4, 6 e visita di discontinuazione al trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Poland
    Spain
    Italy
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 45
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor does not have any plans to provide Roche IMP (giredestrant) or any other study treatments to participants who have completed the study. The Sponsor may evaluate whether to continue providing giredestrant in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website: https://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Lo sponsor non ha in programma di fornire Roche IMP (giredestrant) o altri trattamenti dello studio ai partecipanti che hanno completato lo studio. Lo sponsor può valutare se continuare a fornire giredestrant in conformità con la Roche Global Policy on Continued Access to Investigational Medicinal Product, disponibile al seguente sito web:https://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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