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    Summary
    EudraCT Number:2021-000129-28
    Sponsor's Protocol Code Number:VHP
    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:2021-10-19
    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 number2021-000129-28
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER.
    STUDIO MULTICENTRICO DI FASE III, RANDOMIZZATO, IN APERTO, VOLTO A VALUTARE L'EFFICACIA E LA SICUREZZA DI GIREDESTRANT ADIUVANTE RISPETTO ALLA MONOTERAPIA ENDOCRINA ADIUVANTE DI SCELTA DEL MEDICO IN PAZIENTI CON CARCINOMA MAMMARIO PRECOCE POSITIVO AL RECETTORE DEGLI ESTROGENI E HER2 NEGATIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer.
    Studio volto a valutare l'efficacia e la sicurezza di Giredestrant adiuvante rispetto alla monoterapia endocrina adiuvante di scelta del medico in pazienti con carcinoma mammario precoce positivo al recettore degli estrogeni e HER2 negativo.
    A.3.2Name or abbreviated title of the trial where available
    lidERA/GO42784
    lidERA/GO42784
    A.4.1Sponsor's protocol code numberVHP
    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 1
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    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.2.1.1.1Trade name Giredestrant
    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 [RO7197597]
    D.3.4Pharmaceutical form Capsule
    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.3.8INN - Proposed INNGiredestrant
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Tamoxifen
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTamoxifen
    D.3.2Product code [Tamoxifen]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNTAMOXIFENE CITRATO
    D.3.9.1CAS number 10540-29-1
    D.3.9.2Current sponsor codeRo 021-8627
    D.3.9.4EV Substance CodeSUB10825MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name LETROZOLE
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLetrozolo
    D.3.2Product code [Letrozolo]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNLETROZOLO
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeRo 489-7779
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Anastrozole
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAnastrozolo
    D.3.2Product code [Anastrozolo]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNANASTROZOLO
    D.3.9.2Current sponsor codeRo 071-8807
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Exemestane
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameExemestane
    D.3.2Product code [Exemestane]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNEXEMESTANE
    D.3.9.2Current sponsor codeRo 532-4663
    D.3.9.4EV Substance CodeSUB07492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Estrogen receptor-positive, HER2-negative early breast cancer.
    Carcinoma mammario precoce positivo al recettore degli estrogenti e HER2 negativo.
    E.1.1.1Medical condition in easily understood language
    Breast cancer is a disease in which cells in the breast grow out of control.
    Il carcinoma mammario è una patologia in cui le cellule della mammella proliferano in maniera incontrollata.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive breast cancer
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10083232
    E.1.2Term HER2 negative breast 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
    The primary objective is to demonstrate superiority of the Giredestrant over the control treatment.
    L'obiettivo primario è quello di dimostrare la superiorità di Giredestrant rispetto al trattamento di controllo.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of giredestrant compared with TPC
    - To evaluate the safety of giredestrant compared with TPC
    - To characterize giredestrant PK
    - To evaluate health status utility scores of participants treated with giredestrant compared with TPC
    - Valutare l’efficacia di giredestrant rispetto a TPC
    - Valutare la sicurezza di giredestrant rispetto a TPC
    - Caratterizzare la PK di giredestrant
    - Valutare i punteggi di utilità dello stato di salute dei partecipanti trattati con giredestrant rispetto a TPC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants (females, regardless of menopausal status, and males) who are age >=18 years at the time of signing Informed Consent Form
    • Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are eligible if all examined tumors meet pathologic criteria for estrogen receptor (ER) positivity and HER2 negativity
    • Participants who have documented ER+ tumor by immunohistochemistry (IHC), as assessed locally on a primary disease specimen and defined as >=1% of tumor cells stained positive according to American Society of Clinical Oncology
    ASCO)/College of American Pathologists (CAP) guidelines
    • Participants who have documented HER2- (negative) tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
    • Participants must have undergone definitive surgery of the primary breast tumor(s)
    • Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization
    • Participants for whom resolution of all acute toxic effects of prior anticancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
    • Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy (ET) are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
    • Participants who have confirmed availability of a tumor tissue specimen suitable for biomarker testing, with associated de-identified pathology report is required
    • Participants with no pathological involved nodes (pN0) are eligible if they meet additional criteria
    • Participants with N1 disease are eligible if they meet additional criteria
    • Any T and N2
    • Any T and N3
    • T4 and any N
    • Participant who have Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0, 1 or 2
    • Participants who are able and willing to swallow and retain oral medication
    • Participants who have adequate organ function
    • For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception (women assigned to tamoxifen must also agree to refrain from donating eggs) during the treatment period and for 9 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of TPC (i.e., 60 days after the final dose of tamoxifen-women must refrain from donating eggs during this same period; 21 days after the final dose of letrozole or anastrozole; 30 days after the final dose of exemestane)
    • For men assigned: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 9 days after the final dose of giredestrant within the time period specified per local prescribing guidelines after the final dose of TPC (i.e., 90 days after the final dose of tamoxifen; 21 days after the final dose of letrozole or anastrozole; 30 days after the final dose of exemestane) to avoid exposing the embryo
    • Participants are willing and able to use the electronic device(s) or application for electronic patient-reported outcome (ePRO)
    • For participants enrolled in the extended China enrollment phase: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
    -Femmine e maschi che hanno >= 18 anni di età in grado di fornire un consenso informato firmato
    -Partecipanti con un carcinoma mammario multicentrico e/o multifocale, se tutti i tumori esaminati soddisfano i criteri patologici per la positività ER e la negatività HER2
    -Partecipanti con un tumore ER+ documentato mediante IHC, come valutato localmente su un campione di malattia primaria e definito come >= 1% delle cellule tumorali colorate positivamente secondo le linee guida dell'ASCO/CAP
    -Partecipanti con un tumore HER2- documentato, come valutato localmente su un campione di malattia primaria e definito secondo le linee guida ASCO/CAP
    -I partecipanti devono essere stati sottoposti a intervento chirurgico definitivo del carcinoma mammario primario (eccezioni descritte nel protocollo)
    I margini del campione resecato devono essere istologicamente liberi da tumore invasivo e/o da una componente di DCIS come determinato dal patologo locale. Se il tumore è ancora presente al margine resecato dopo la re-escissione, il partecipante deve essere sottoposto a mastectomia per essere idoneo. I partecipanti con margini positivi per il LCIS sono eleggibili senza ulteriore resezione
    -I partecipanti che hanno ricevuto o riceveranno chemioterapia (neo) adiuvante devono aver completato la chemioterapia adiuvante prima della randomizzazione. È necessario un periodo di washout di almeno 21 giorni tra l'ultima dose di chemioterapia adiuvante e la randomizzazione.
    -Partecipanti che hanno manifestato risoluzione di tutti gli effetti tossici acuti della precedente terapia antitumorale o delle procedure chirurgiche al Grado 1 o superiore secondo NCI CTCAE v5.0 (eccezioni descritte nel protocollo)
    -I partecipanti che hanno ricevuto chemioterapia (neo)adiuvante e/o hanno subito un intervento chirurgico e non hanno avuto terapia endocrina (ET) precedente sono eleggibili, a condizione che siano arruolati entro 12 mesi dall'intervento chirurgico definitivo per carcinoma mammario
    -I partecipanti che hanno disponibilità di un campione di tessuto tumorale adatto all'analisi dei biomarcatori con relativo referto patologico de identificato
    -Per la determinazione dell'eleggibilità sulla base del punteggio Ki67, un campione di tessuto del carcinoma mammario ottenuto prima di qualsiasi esposizione alla terapia sistemica deve essere presentato durante lo screening per essere analizzato da un laboratorio patologico centrale
    -I partecipanti senza linfonodi patologicamente coinvolti (pN0) devono avere un tumore primario più grande di 1 cm e inoltre devono rientrare nelle caratteristiche considerate “rischio medio”
    -Partecipanti con tumore primario T4 e eventuali N (alto rischio)
    -Presentare stato di performance ECOG di 0, 1 o 2.
    -Partecipanti che sono in grado e disposti a deglutire e trattenere i farmaci per via orale
    -I pazienti devono presentare una funzione d'organo adeguata come definita dai seguenti criteri:
    -ANC >=1 x 10^9/L
    -Conta delle piastrine >= 100 x 10^9/L
    -AST e ALT sierica <= x ULN
    -ALP <= 2 volte ULN
    -Emoglobina >= 80 g/L
    -Bilirubina sierica <=1.5 x ULN con la seguente eccezione:
    Partecipanti con sindrome di Gilbert nota: <= 3 x ULN
    -Clearance della creatinina stimata >= 60 mL/min e calcolata secondo le linee guida istituzionali
    -INR < 1.5 x ULN e PTT (o aPTT) < 1.5 x ULN
    -Per i partecipanti che ricevono eparina, è richiesto un PTT (o aPTT) compreso tra 1.5 x e 2.5 x ULN (o il valore del partecipante prima di iniziare il trattamento con eparina).
    -Per le donne in età fertile: devono accettare di praticare l'astinenza o di usare metodi contraccettivi (le donne assegnate a tamoxifene devono anche accettare di astenersi dalla donazione di ovuli) in conformità a quanto definito nel protocollo.
    -Partecipanti maschili devono accettare di praticare l'astinenza o di usare metodi contraccettivi e accettare di astenersi dalla donazione di sperma, in conformità a quanto definito nel protocollo
    -Altri criteri di inclusione sono descritti nel protocollo
    E.4Principal exclusion criteria
    • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC
    • Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
    • Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
    • Participants who have active cardiac disease or history of cardiac dysfunction
    • Participants who have been diagnosed with Stage IV breast cancer or inflammatory breast cancer
    • Participants who have a history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
    • Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible
    • Participants who have a or history of any other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
    • Participants who have had any prior endocrine treatment with selective ER down-regulators or degraders or aromatase inhibitor (AI)
    • Participants who have a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
    • Participants who have a known allergy or hypersensitivity to any of the study drugs or any of their excipients
    • Pre- and perimenopausal participants or male participants who have a known hypersensitivity to luteinizing hormone-releasing hormone (LHRH) agonists
    • Participants who have known issues with swallowing oral medication
    • Participants who have a documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
    • Participants who have a malabsorption syndrome or other condition that would interfere with enteral absorption
    • Participants who have uncontrolled inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery
    • Participants who have had a major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation ofthe need for major surgery during study treatment
    • Participants who have had a serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
    • Participants who have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
    • Participants who are unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator
    -Partecipanti che sono in gravidanza o che allattano, o che intendono iniziare una gravidanza durante lo studio o entro 9 giorni dopo la dose finale di giredestrant, o per il periodo di tempo specificato dalle linee guida locali di prescrizione dopo la dose finale di TPC.
    -Le donne in età fertile devono avere un risultato negativo al test di gravidanza sul siero nei 7 giorni prima dell'inizio del trattamento in studio.
    -Partecipanti che hanno ricevuto un trattamento con una terapia sperimentale entro 28 giorni prima dell'inizio del trattamento in studio o che sono attualmente arruolati a qualsiasi altro tipo di ricerca medica giudicata dallo sponsor non scientificamente o medicalmente compatibile con questo studio
    -Partecipanti che ricevono o prevedono di ricevere un CDK4/6i come terapia adiuvante
    -Partecipanti che hanno una malattia cardiaca attiva o un'anamnesi di disfunzione cardiaca (dettagli nel protocollo),
    -Partecipanti a cui è stato diagnosticato un carcinoma mammario al IV stadio o un carcinoma mammario infiammatorio
    -Partecipanti che hanno un’anamnesi di eventuale precedente carcinoma mammario invasivo o DCIS (ipsilaterale e/o controlaterale). I partecipanti con un’anamnesi di DCIS controlaterale trattato solo con terapia regionale locale in qualsiasi momento possono essere eleggibili.
    -Partecipanti che hanno o hanno avuto un qualsiasi altro tumore maligno nei 5 anni precedenti lo screening, ad eccezione del carcinoma in situ della cervice uterina adeguatamente trattato, del carcinoma della pelle non melanoma o del cancro all'utero in stadio I. (dettagli nel protocollo)
    -Partecipanti che hanno ricevuto un qualsiasi trattamento endocrino precedente con down-regolatori o degradatori ER selettivi o AI (dettagli nel protocollo)
    -Partecipanti che hanno una anamnesi clinicamente significativa di malattia epatica coerente con Child-Pugh classe B o C, compresa l'epatite (ad esempio, [HBV] o [HCV]), attuale abuso di alcol, cirrosi, o test positivo per l'epatite virale (dettagli nel protocollo)
    -Partecipanti che hanno un'allergia o un'ipersensibilità nota a uno dei farmaci in studio o a uno dei loro eccipienti
    -Partecipanti in pre e perimenopausa o partecipanti di sesso maschile che hanno una nota ipersensibilità agli agonisti dell’LHRH
    -Partecipanti che hanno problemi noti con la deglutizione di farmaci orali
    -Partecipanti che hanno un’anamnesi documentata di diatesi emorragica, coagulopatia o tromboembolia
    -Anamnesi di sindrome da malassorbimento o altre condizioni che potrebbero interferire con l'assorbimento intestinale
    -Partecipanti che hanno una malattia infiammatoria intestinale non controllata o diarrea cronica, sindrome dell'intestino corto, o intervento chirurgico importante al tratto gastrointestinale superiore
    -Partecipanti che hanno subito un intervento chirurgico importante non correlato al carcinoma mammario entro 28 giorni prima della randomizzazione o la previsione della necessità di un intervento chirurgico importante durante il trattamento in studio
    -Partecipanti che hanno avuto un'infezione grave che ha richiesto antibiotici orali o EV nei 14 giorni precedenti lo screening o un'altra infezione clinicamente significativa (ad esempio, COVID-19) nei 14 giorni precedenti lo screening
    -Sono eleggibili i partecipanti che sono completamente guariti da infezioni gravi o clinicamente significative almeno 14 giorni prima dello screening.
    Se un partecipante mostra segni o sintomi di una potenziale infezione da COVID-19 e c'è un ragionevole sospetto di esposizione, gli sperimentatori devono seguire le linee guida dell'American Society of Clinical Oncology 2020 o le linee guida istituzionali sui test.
    -Qualsiasi condizione clinica seria o anomalia dei test clinici di laboratorio che, a giudizio dello sperimentatore, preclude al paziente una partecipazione sicura e il completamento dello studio.
    -Partecipanti che, a giudizio dello sperimentatore, non sono in grado o non vogliono rispettare i requisiti del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    IDFS is defined as the time from randomization to first occurrence of one of the following IDFS events
    – Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion)
    – Ipsilateral locoregional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast)
    – Distant recurrence (i.e., evidence of breast cancer in any anatomic site other than the two sites mentioned above that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer)
    – Contralateral invasive breast cancer
    – Death from any cause, including breast cancer, non-breast cancer, or unknown cause (but the cause of death should be specified, if possible). All second primary non-breast cancers and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancers will be excluded as an event for this endpoint
    La sopravvivenza libera da malattia invasiva (IDFS) è definita come il tempo dalla randomizzazione alla prima insorgenza di uno dei seguenti eventi IDFS
    – Recidiva di carcinoma mammario invasivo ipsilaterale (ovvero, un carcinoma mammario invasivo che coinvolge lo stesso parenchima mammario della lesione primaria originale)
    – Recidiva locoregionale di carcinoma mammario invasivo ipsilaterale (ovvero, un carcinoma mammario invasivo nell'ascella, nei linfonodi regionali, nella parete toracica e/o nella pelle della mammella ipsilaterale)
    – Recidiva distante (ovvero, evidenza di carcinoma mammario in qualsiasi sede anatomica diversa dalle due sedi menzionate sopra, che sia stato confermato istologicamente o diagnosticato clinicamente come carcinoma mammario invasivo ricorrente)
    – Carcinoma mammario invasivo controlaterale
    – Decesso per qualsiasi causa, compreso il carcinoma mammario, tumore non mammario, o causa non nota (ma la causa del decesso deve essere specificata, se possibile)
    Tutti i secondi tumori primari non della mammella e i carcinomi in situ (inclusi carcinoma duttale in situ [DCIS] e carcinoma lobulare in situ [LCIS]) e i tumori della pelle non melanoma saranno esclusi come evento per questo endpoint
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization until the first occurrence of IDFS event or death, through the end of study (Up to approximately 10 years [Screening: Day -28 to -1; Treatment: At least 5 years; Follow-up: 5 years])
    Randomizzazione fino al verificarsi del primo evento IDFS o alla morte, fino alla fine dello studio (fino a circa 10 anni [Screening: da giorno -28 a -1; Trattamento: almeno 5 anni; Follow-up: 5 anni])
    E.5.2Secondary end point(s)
    - Overall survival, defined as the time from randomization to death from any cause
    - IDFS (per STEEP; Hudis et al. 2007), including second primary non-breast cancer, defined in the
    same way as the primary IDFS, but including second primary non-breast invasive cancer as an event (with the exception of non-melanoma skin cancers and in situ carcinomas of any site)
    - DFS, defined as the time from randomization to first occurrence of an IDFS (per STEEP) event, including second primary non-breast cancer event or contralateral or ipsilateral DCIS (See Table 7)
    - DRFI, defined as the time from randomization to first occurrence of a DRFI event
    - LRRFI, defined as the time from randomization to first occurrence of a LRRFI event
    - Mean and mean change from baseline in physical functioning, role functioning, and global health status/QoL at relevant timepoints as assessed through use of the EORTC QLQ-C30 respective scale scores
    - Incidence and severity of adverse events, with severity determined according to NCI CTCAE 5.0
    - Change from baseline in targeted vital signs and clinical laboratory test results
    - Plasma concentrations of giredestrant at specified timepoints
    - Change from baseline in EQ 5D-5L index-based and visual analogue scale scores at relevant imepoint
    - Sopravvivenza globale, definita come il periodo che va dalla randomizzazione fino al decesso per qualsiasi causa
    - IDFS (secondo STEEP; Hudis et al. 2007), incluso il secondo tumore primario non della mammella, definita allo stesso modo dell'IDFS primaria, ma includendo il secondo tumore primario invasivo non della mammella come evento (con l'eccezione dei tumori della pelle non melanoma e dei carcinomi in situ di qualsiasi sito)
    - DFS, definita come il tempo dalla randomizzazione alla prima comparsa di un evento IDFS (secondo i criteri STEEP), incluso l’evento di secondo tumore primario non della mammella o DCIS controlaterale o ipsilaterale (vedere Tabella 7)
    - DRFI, definito come il tempo che intercorre tra la randomizzazione e la prima comparsa di un evento DRFI.
    - LRRFI, definito come il tempo che intercorre tra la randomizzazione e la prima comparsa di un evento LRRFI.
    - Media e variazione media dalla baseline nella funzionalità fisica, nella funzionalità di ruolo e nello stato di salute globale/qualità della vita (QoL) ai punti temporali rilevanti come valutato attraverso l'uso dei rispettivi punteggi della scala EORTC QLQ C30
    - Incidenza e gravità degli eventi avversi, con la gravità determinata secondo NCI CTCAE 5.0
    - Variazione dalla baseline nei segni vitali mirati e nei risultati dei test clinici di laboratorio mirati
    - Concentrazioni plasmatiche di giredestrant in determinati punti temporali
    - Variazione dalla baseline nei punteggi dell'indice EQ 5D-5L e della scala analogica visiva al punto temporale rilevante
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to approximately 10 years (Screening: Day -28 to -1; Treatment: At least 5 years; Follow-up: 5 years)
    Fino a circa 10 anni (Screening: da giorno -28 a -1; Trattamento: almeno 5 anni; Follow-up: 5 anni])
    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 Yes
    E.6.13.1Other scope of the trial description
    Health status of participants.
    Stato di salute dei partecipanti.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    Australia
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Costa Rica
    Egypt
    Georgia
    Guatemala
    Hong Kong
    India
    Israel
    Japan
    Kenya
    Korea, Republic of
    North Macedonia
    Malaysia
    Mexico
    Peru
    Philippines
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Thailand
    Turkey
    Uganda
    Ukraine
    United States
    Vietnam
    Austria
    Belgium
    Bulgaria
    Croatia
    Finland
    France
    Germany
    Hungary
    Ireland
    Latvia
    Netherlands
    Poland
    Portugal
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of this study is defined as the date of the last scheduled procedure shown in the schedule of activities for the last participant in the study globally (i.e.: last participant in the global and extended China enrollment phases combined), or the date at which the last data point required for statistical analysis or safety follow-up is received from the last participant (global and extended China enrollment phases combined), whichever occurs later.
    La fine di questo studio è definita come la data dell'ultima procedura pianificata indicata nel programma delle attività per l'ultimo partecipante a livello globale (cioè: l'ultimo partecipante nelle fasi di arruolamento globale ed estesa alla Cina) o la data in cui l'ultimo dato richiesto per l'analisi statistica o il follow-up della sicurezza viene raccolto dall'ultimo partecipante (fasi di arruolamento globale ed estesa alla Cina), qualunque evento si verificasse successivamente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    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 years12
    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: 3100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state83
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1261
    F.4.2.2In the whole clinical trial 4100
    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: http://www.roche.com/policy_continued_access_to_investigational_ medicines.pdf
    Il Promotore non ha in programma di fornire il farmaco sperimentale giredestrant della Roche o qualsiasi altro trattamento oggetto dello studio ai partecipanti che hanno completato lo studio. Il Promotore può valutare se continuare a fornire giredestrant in conformità con la politica globale della Roche sull'accesso continuato al farmaco sperimentale, disponibile sul seguente sito web: http://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 Decision2021-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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