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Um estudo avaliando a eficácia e a segurança de Giredestrant Plus Everolimus em comparação com Exemestane Plus Everolimus em participantes com câncer de mama com receptor de estrogênio positivo, HER2-negativo, localmente avançado ou metastático (câncer de mama evERA)

30 de outubro de 2026 atualizado por: Genentech, Inc.

Um estudo de fase III, randomizado, aberto e multicêntrico avaliando a eficácia e a segurança de Giredestrant mais Everolimus em comparação com Exemestane Plus Everolimus em pacientes com câncer de mama com receptor de estrogênio positivo, HER2 negativo, localmente avançado ou metastático

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

373

Estágio

  • Fase 3

Acesso expandido

Disponível fora do ensaio clínico. Consulte registro de acesso expandido.

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Giredestrant mais Everolimo
Medicamento: 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).

Outros nomes:
  • GDC-9545
  • RO7197597
  • RG6171
Medicamento: 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.

Medicamento: 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.

Medicamento: 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.
Comparador Ativo: Physician's Choice of Endocrine Therapy plus Everolimus

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

Medicamento: 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.

Medicamento: 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.

Medicamento: 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.

Medicamento: 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.

Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sobrevivência geral, na subpopulação ESR1m e população ITT
Prazo: Da randomização até a morte por qualquer causa (até 42 meses)
Da randomização até a morte por qualquer causa (até 42 meses)
Duração da resposta (DOR), conforme determinado pelo investigador de acordo com RECIST v1.1, na subpopulação ESR1m e população ITT
Prazo: Desde a primeira ocorrência de uma resposta objetiva documentada à progressão da doença ou morte por qualquer causa, o que ocorrer primeiro (até 42 meses)
Desde a primeira ocorrência de uma resposta objetiva documentada à progressão da doença ou morte por qualquer causa, o que ocorrer primeiro (até 42 meses)
Número de participantes com pelo menos um evento adverso, com gravidade determinada de acordo com o National Cancer Institute Common Terminology Criteria for Adverse Events, versão 5 (NCI CTCAE v5.0)
Prazo: Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Número de participantes com anormalidades em testes laboratoriais clínicos para parâmetros hematológicos ao longo do estudo
Prazo: Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Número de participantes com anormalidades em testes de laboratório clínico para parâmetros bioquímicos ao longo do estudo
Prazo: Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Da linha de base até 30 dias após a dose final do tratamento do estudo (até 42 meses)
Concentração plasmática de Giredestrant em pontos de tempo especificados
Prazo: Pré-dose e 3 horas pós-dose nos Dias 1 e 15 do Ciclo 1, e pré-dose no Dia 1 dos Ciclos 2 e 3 (1 ciclo é de 28 dias)
Pré-dose e 3 horas pós-dose nos Dias 1 e 15 do Ciclo 1, e pré-dose no Dia 1 dos Ciclos 2 e 3 (1 ciclo é de 28 dias)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Genentech, Inc.

Investigadores

  • Diretor de estudo: Clinical Trials, Genentech, Inc.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de agosto de 2022

Conclusão Primária (Real)

16 de julho de 2025

Conclusão do estudo (Estimado)

15 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de março de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de março de 2022

Primeira postagem (Real)

1 de abril de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ML43171
  • 2022-000199-20 (Número EudraCT)
  • 2023-506821-12-00 (Identificador de registro: CTIS (EU))
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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