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Uno studio che valuta l'efficacia e la sicurezza di Giredestrant Plus Everolimus rispetto a Exemestane Plus Everolimus in partecipanti con carcinoma mammario positivo al recettore degli estrogeni, HER2 negativo, localmente avanzato o metastatico (cancro al seno evERA)

30 ottobre 2026 aggiornato da: Genentech, Inc.

Uno studio di fase III, randomizzato, in aperto, multicentrico che valuta l'efficacia e la sicurezza di giredestrant più everolimus rispetto a exemestane più everolimus in pazienti con carcinoma mammario positivo per il recettore degli estrogeni, HER2 negativo, localmente avanzato o metastatico

This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

373

Fase

  • Fase 3

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski
      • Mendoza, Argentina, M5500AYB
        • Fundacion Centro Oncologico de Integracion Regional (COIR)
      • Rosario, Argentina, S2000DEJ
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Argentina, S2002KDS
        • Hospital Provincial del Centenario
      • Rosario, Argentina, S2013KZE
        • Instituto de Oncologia de Rosario
      • San Juan, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
      • San Nicolás, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • Viedma, Argentina, R8500ACE
        • Centro de Investigación Clínica ? Clínica Viedma
    • Ciudad Autónoma de BuenosAires
      • Agronomía, Ciudad Autónoma de BuenosAires, Argentina, C1417DTB
        • Instituto de Oncología Ángel H. Roffo
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
        • Centro de Investigaciones Médicas y Desarrollo LC S.R.L
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5008AAC
        • Centro Medico Privado CEMAIC
  • Corea del Sud
      • Cheongju-si, Corea del Sud, 28644
        • Chungbuk National University Hospital
      • Dongnam-gu, Cheonan-si, Corea del Sud, 31151
        • Soon Chun Hyang University Cheonan Hospital
      • Goyang-si, Corea del Sud, 10408
        • National Cancer Center
      • Seongnam-si, Corea del Sud, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sud, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sud, 08308
        • Korea University Guro Hospital
      • Seoul, Corea del Sud, 03722
        • Severance Hospital Yonsei University Health System - PPDS
  • Germania
      • Bottrop, Germania, 46236
        • Knappschaft Kliniken Marienhospital Bottrop
      • Erlangen, Germania, 91054
        • Universitatsklinikum Erlangen
      • Essen, Germania, 45136
        • Kliniken Essen-Mitte
      • Heidelberg, Germania, 69120
        • Universitätsklinikum Heidelberg
      • Mainz, Germania, 55101
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Giappone
      • Aichi, Giappone, 464-8681
        • Aichi Cancer Center
      • Aichi, Giappone, 466-8560
        • Nagoya University Hospital
      • Chiba, Giappone, 260-8717
        • Chiba Cancer Center
      • Chiba, Giappone, 277-8577
        • National Cancer Center Hospital East
      • Ehime, Giappone, 791-0280
        • Shikoku Cancer Center
      • Hiroshima, Giappone, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hiroshima, Giappone, 734-8551
        • Hiroshima University Hospital
      • Hokkaido, Giappone, 060-8648
        • Hokkaido University Hospital
      • Hyōgo, Giappone, 673-0021
        • Hyogo Cancer Center
      • Ibaraki, Giappone, 305-8576
        • University of Tsukuba Hospital
      • Kanagawa, Giappone, 241-8515
        • Kanagawa Cancer Center
      • Kanagawa, Giappone, 259-1193
        • Tokai University Hospital
      • Kumamoto, Giappone, 860-8556
        • Kumamoto University Hospital
      • Niigata, Giappone, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Giappone, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Tokyo, Giappone, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Giappone, 113-8431
        • Juntendo University Hospital
  • Grecia
      • Athens, Grecia, 12464
        • Attikon University General Hospital
      • Athens, Grecia, 115 27
        • University of Athens, Hematological Clinic,
      • Cholargós, Grecia, 155 62
        • Metropolitan General Hospital
      • Heraklio, Grecia, 711 10
        • University General Hospital of Heraklion
      • Larissa, Grecia, 412 21
        • University General Hospital of Larissa
      • Marousi, Grecia, 151 23
        • IASO Obstetrics Gynecology Clinic
      • Panórama, Grecia, 552 36
        • Agios Loucas Clinic SA
      • Piraeus, Grecia, 185 37
        • Metaxa Cancer Hospital of Piraeus
      • Pátrai, Grecia, 264 43
        • Olympion Clinic
      • Thessaloniki, Grecia, 546 39
        • Interbalkan Medical Center of Thessaloniki
  • Italia
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italia, 41110
        • Azienda Ospedaliero - Universitaria di Modena Policlinico
    • Lazio
      • Rome, Lazio, Italia, 00144
        • Istituto Nazionale Tumori Regina Elena IRCCS
    • Liguria
      • Genoa, Liguria, Italia, 16132
        • IRCCS AOM Azienda Ospedaliera Metropolitana
    • Lombardy
      • Milan, Lombardy, Italia, 20162
        • Asst Grande Ospedale Metropolitano Niguarda
    • The Marches
      • Torrette Di Ancona, The Marches, Italia, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
    • Veneto
      • Verona, Veneto, Italia, 37124
        • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
  • Regno Unito
      • Dorchester, Regno Unito, DT1 2JY
        • Dorset County Hospital
      • London, Regno Unito, N18 1QX
        • North Middlesex Uni Hospital
      • Nottingham, Regno Unito, NG5 1PB
        • Nottingham City Hospital
    • Manchester
      • Manchester, Manchester, Regno Unito, M20 4BX
        • The Christie NHS Foundation Trust - SSC Parent
  • Singapore
      • Singapore, Singapore, 117599
        • National University Hospital
      • Singapore, Singapore, 258500
        • Oncocare Cancer Centre
  • Spagna
    • BARCELONA
      • Barcelona, BARCELONA, Spagna, 08028
        • Hospital Dexeus
      • Barcelona, BARCELONA, Spagna, 08036
        • Hospital Clinic de Barcelona
    • CORDOBA
      • Córdoba, CORDOBA, Spagna, 14004
        • C.H. Regional Reina Sofia - PPDS
    • LA CORUNA
      • A Coruña, LA CORUNA, Spagna, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
    • Madrid
      • Madrid, Madrid, Spagna, 28040
        • Hospital Clinico San Carlos
      • Madrid, Madrid, Spagna, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spagna, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Madrid, Spagna, 28007
        • Hospital General Universitario Gregorio Marañon
    • Murcia
      • Murcia, Murcia, Spagna, 30008
        • Hospital General Universitario J.M Morales Meseguer
    • Valencia
      • Valencia, Valencia, Spagna, 46010
        • Hospital Clinico Universitario de Valencia
  • Stati Uniti
    • Alaska
      • Anchorage, Alaska, Stati Uniti, 99508
        • Alaska Oncology & Hematology, LLC
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85711
        • Arizona Oncology Associates, PC-CASA
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205-7199
        • University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Stati Uniti, 94704
        • Alta Bates Summit Medical Center
      • Beverly Hills, California, Stati Uniti, 90211
        • Beverly Hills Cancer Center
      • Cerritos, California, Stati Uniti, 90703
        • TOI Clinical Research
      • Fresno, California, Stati Uniti, 93710
        • Women's Cancer Care
      • La Jolla, California, Stati Uniti, 92037
        • Scripps Health
      • Los Angeles, California, Stati Uniti, 90017
        • Los Angeles Hematology Oncology Medical Group
      • Orange, California, Stati Uniti, 92868
        • University of California, Irvine Medical Center
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale Cancer Center
    • Florida
      • Miami Beach, Florida, Stati Uniti, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, Stati Uniti, 32806
        • Orlando Health Cancer Institute
    • Georgia
      • Marietta, Georgia, Stati Uniti, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
      • Savannah, Georgia, Stati Uniti, 31405
        • Summit Cancer Care PC
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
      • Springfield, Illinois, Stati Uniti, 62702
        • Springfield Clinic
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Kansas
      • Westwood, Kansas, Stati Uniti, 66205
        • University of Kansas Cancer Center
    • Maine
      • Brewer, Maine, Stati Uniti, 04412
        • Eastern Maine Medical Center
      • Scarborough, Maine, Stati Uniti, 04074
        • New England Cancer Specialists
    • Maryland
      • Annapolis, Maryland, Stati Uniti, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Dana Farber Cancer Institute
    • Minnesota
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Metro-Minnesota Community Oncology Research Consortium
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68103
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists
    • Nevada
      • Reno, Nevada, Stati Uniti, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Memorial Sloan Kettering - Basking Ridge
      • Middletown, New Jersey, Stati Uniti, 07748
        • Memorial Sloan Kettering - Monmouth
    • New Mexico
      • Farmington, New Mexico, Stati Uniti, 87401
        • San Juan Oncology Associates
    • New York
      • New York, New York, Stati Uniti, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Stati Uniti, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Stati Uniti, 10011
        • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
      • Stony Brook, New York, Stati Uniti, 11794
        • Stony Brook University Medical Center
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43219
        • SCRI Mark H. Zangmeister Center
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74146
        • Oklahoma Cancer Specialists and Research Institute
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • St Charles Medical Center Bend
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • UPMC Hillman Cancer Center - Magee-Women?s Hospital
      • West Chester, Pennsylvania, Stati Uniti, 19380
        • Abramson Cancer Center Chester County Hospital
      • West Reading, Pennsylvania, Stati Uniti, 19611
        • McGlinn Cancer Institute at Reading Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Avera Cancer Institute
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • West Cancer Center
    • Texas
      • Bedford, Texas, Stati Uniti, 76022
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, Stati Uniti, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Denton, Texas, Stati Uniti, 76201
        • Texas Oncology-Denton South
      • El Paso, Texas, Stati Uniti, 79902
        • Texas Oncology, P.A. - El Paso
      • Houston, Texas, Stati Uniti, 77030
        • Houston Methodist Cancer Center
      • Houston, Texas, Stati Uniti, 77090
        • Millennium Research & Clinical Development
      • San Antonio, Texas, Stati Uniti, 78229
        • Texas Oncology P.A.
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Virginia Cancer Specialists
      • Fairfax, Virginia, Stati Uniti, 22031
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Stati Uniti, 23502
        • Virginia Oncology Associates
    • Washington
      • Tacoma, Washington, Stati Uniti, 98405
        • Northwest Medical Specialties, PLLC
  • Sud Africa
      • Johannesburg, Sud Africa, 2196
        • Medical Oncology Centre of Rosebank
  • Taiwan
      • Chang-hua, Taiwan, 500
        • Changhua Christian Hospital
      • Kaohsiung Country, Taiwan, 833
        • Chang Gung Memorial Hospital
      • Tainan, Taiwan, 70457
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 100229
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Chang Gung Memorial Hospital - Linkou Branch
  • Turchia (Türkiye)
      • Ankara, Turchia (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Sakarya, Turchia (Türkiye), 811
        • SAKARYA University Medical Faculty

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

  2. Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally

  3. Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing

  4. Prior endocrine therapy (ET) in combination with cyclin-dependent kinase 4/6 inhibitors in either setting as follows:

    • Metastatic setting: Disease progression after ≥6 months on ET plus CDK4/6 inhibitor in the locally advanced or metastatic setting. If ET plus CDK4/6 inhibitor is not the most recent therapy, then patient must also have had disease progression after ≥4 months on most recent ET
    • Adjuvant Setting: Relapse either while taking or within 12 months of exposure to combination adjuvant ET and CDK4/6 inhibitor. Patients must have taken at least 12 months of adjuvant ET, 6 months of which was in combination with a CDK4/6 inhibitor.

  5. Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases. Patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) which can be followed

  6. Eastern Cooperative Oncology Group Performance Status 0-1

  7. For women who are premenopausal or perimenopausal and for men: treatment with approved luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment

Exclusion Criteria:

  1. Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed.
  2. Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
  3. Prior chemotherapy for locally advanced unresectable or metastatic disease
  4. Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
  5. Treatment with any investigational therapy within 28 days prior to initiation of study treatment
  6. Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
  7. History of any other malignancy other than breast cancer within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence
  8. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  9. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  10. Active cardiac disease or history of cardiac dysfunction
  11. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis
  12. Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
  13. Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
  14. Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization
  15. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  16. Known allergy or hypersensitivity to any of the study drugs or any of their excipients
  17. For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists
  18. Pregnant or breastfeeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Giredistrante più Everolimus
Droga: Giredestrant

Participants will receive treatment with giredestrant 30 milligrams (mg) orally once a day (QD) on Days 1-28 of each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

Altri nomi:
  • GDC-9545
  • RO7197597
  • RG6171
Droga: Everolimus

Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Droga: LHRH Agonist

Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Droga: Dexamethasone Mouth Rinse

A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms.
Comparatore attivo: Physician's Choice of Endocrine Therapy plus Everolimus

The physician's choice of endocrine therapy is defined as either exemestane, fulvestrant, or tamoxifen.
Droga: Everolimus

Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Droga: LHRH Agonist

Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Droga: Dexamethasone Mouth Rinse

A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms.

Droga: Exemestane

If exemestane is chosen as the physician's choice of endocrine therapy, the participant will receive exemestane at a dose of 25 mg orally once a day (QD) on Days 1-28 of each 28-day cycle or as per local label, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

Droga: Fulvestrant

If fulvestrant is chosen as the physician's choice of endocrine therapy, the participant will receive fulvestrant in the clinic at a dose of 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, then Day 1 of each cycle thereafter (1 cycle is 28 days) or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

Droga: Tamoxifen

If tamoxifen is chosen as the physician's choice of endocrine therapy, the participant will receive tamoxifen at a dose of 20 mg orally QD on Days 1-28 of each 28-day cycle or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)

The Intent-to-Treat (ITT) population consists of all randomized participants, and the ESR1m subpopulation is defined as participants in the ITT population whose tumors harbor a detectable Estrogen Receptor 1 (ESR1) mutation at baseline as measured in circulating tumor DNA (ctDNA).
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sopravvivenza globale, nella sottopopolazione ESR1m e nella popolazione ITT
Lasso di tempo: Dalla randomizzazione fino alla morte per qualsiasi causa (fino a 42 mesi)
Dalla randomizzazione fino alla morte per qualsiasi causa (fino a 42 mesi)
Durata della risposta (DOR), determinata dallo sperimentatore secondo RECIST v1.1, nella sottopopolazione ESR1m e nella popolazione ITT
Lasso di tempo: Dalla prima occorrenza di una risposta obiettiva documentata alla progressione della malattia o alla morte per qualsiasi causa, a seconda di quale si verifichi per prima (fino a 42 mesi)
Dalla prima occorrenza di una risposta obiettiva documentata alla progressione della malattia o alla morte per qualsiasi causa, a seconda di quale si verifichi per prima (fino a 42 mesi)
Numero di partecipanti con almeno un evento avverso, con gravità determinata secondo i Common Terminology Criteria for Adverse Events del National Cancer Institute, versione 5 (NCI CTCAE v5.0)
Lasso di tempo: Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Numero di partecipanti con anomalie dei test di laboratorio clinici per i parametri ematologici nel corso dello studio
Lasso di tempo: Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Numero di partecipanti con anomalie dei test di laboratorio clinici per i parametri biochimici nel corso dello studio
Lasso di tempo: Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Dal basale fino a 30 giorni dopo la dose finale del trattamento in studio (fino a 42 mesi)
Concentrazione plasmatica di Giredestrant in punti temporali specificati
Lasso di tempo: Pre-dose e 3 ore post-dose nei Giorni 1 e 15 del Ciclo 1 e pre-dose nel Giorno 1 dei Cicli 2 e 3 (1 ciclo è di 28 giorni)
Pre-dose e 3 ore post-dose nei Giorni 1 e 15 del Ciclo 1 e pre-dose nel Giorno 1 dei Cicli 2 e 3 (1 ciclo è di 28 giorni)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until progressive disease or death (up to 42 months)

The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart.
From randomization until progressive disease or death (up to 42 months)
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From Baseline until progressive disease or death (up to 42 months)

The clinical benefit rate is defined as the percentage of participants with stable disease for at least (≥)24 weeks or a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart.
From Baseline until progressive disease or death (up to 42 months)
Time to Confirmed Deterioration in Pain Severity, as Determined Using the Brief Pain Inventory Short-Form (BPI-SF) Worst Pain Item Score, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until 90 days after treatment discontinuation (up to 42 months)

Time to confirmed deterioration in pain severity is defined as the time from randomization to the first documentation of ≥2-point increase from baseline on the "worst pain" item score (scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine") held for 2 consecutive time points, or a ≥2-point increase followed by death attributable to cancer progression within 28 days from the last assessment.
From randomization until 90 days after treatment discontinuation (up to 42 months)
Time to Confirmed Deterioration in Pain Presence and Interference, as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed Pain Scale Score, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until 90 days after treatment discontinuation (up to 42 months)

Time to confirmed deterioration in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score held for 2 consecutive time points, or a ≥10-point increase followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30
From randomization until 90 days after treatment discontinuation (up to 42 months)
Time to Confirmed Deterioration in Physical Functioning (PF), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed PF Scale Score, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until 90 days after treatment discontinuation (up to 42 months)

Time to confirmed deterioration in physical functioning (PF) is defined as the time from randomization to the first documentation of ≥10-point decrease in PF score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30
From randomization until 90 days after treatment discontinuation (up to 42 months)
Time to Confirmed Deterioration in Role Functioning (RF), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed RF Scale Score, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until 90 days after treatment discontinuation (up to 42 months)

Time to confirmed deterioration in role functioning (RF) is defined as the time from randomization to the first documentation of ≥10-point decrease in RF score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30
From randomization until 90 days after treatment discontinuation (up to 42 months)
Time to Confirmed Deterioration in Health-Related Quality of Life (HRQoL), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed Global Health Status (GHS)/QoL Scale Score, in the ESR1m Subpopulation and ITT Population
Lasso di tempo: From randomization until 90 days after treatment discontinuation (up to 42 months)

Time to confirmed deterioration in HRQoL is defined as the time from randomization to the first documentation of ≥10-point decrease in GHS/QoL score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30
From randomization until 90 days after treatment discontinuation (up to 42 months)
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Lasso di tempo: From Baseline until 30 days after the final dose of study treatment (up to 42 months)

Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.
From Baseline until 30 days after the final dose of study treatment (up to 42 months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genentech, Inc.

Investigatori

  • Direttore dello studio: Clinical Trials, Genentech, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 agosto 2022

Completamento primario (Effettivo)

16 luglio 2025

Completamento dello studio (Stimato)

15 giugno 2027

Date di iscrizione allo studio

Primo inviato

23 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

23 marzo 2022

Primo Inserito (Effettivo)

1 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML43171
  • 2022-000199-20 (Numero EudraCT)
  • 2023-506821-12-00 (Identificatore di registro: CTIS (EU))
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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