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Een studie ter evaluatie van de werkzaamheid en veiligheid van Giredestrant plus everolimus in vergelijking met exemestane plus everolimus bij deelnemers met oestrogeenreceptor-positieve, HER2-negatieve, lokaal gevorderde of gemetastaseerde borstkanker (evERA-borstkanker)

30 oktober 2026 bijgewerkt door: Genentech, Inc.

Een fase III, gerandomiseerde, open-label, multicenter studie ter evaluatie van de werkzaamheid en veiligheid van Giredestrant plus everolimus in vergelijking met exemestaan ​​plus everolimus bij patiënten met oestrogeenreceptor-positieve, HER2-negatieve, lokaal gevorderde of gemetastaseerde borstkanker

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

373

Fase

  • Fase 3

Uitgebreide toegang

Verkrijgbaar buiten de klinische proef. Zie uitgebreid toegangsrecord.

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Giredestrant plus Everolimus
Geneesmiddel: 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).

Andere namen:
  • GDC-9545
  • RO7197597
  • RG6171
Geneesmiddel: 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.

Geneesmiddel: 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.

Geneesmiddel: 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.
Actieve vergelijker: Physician's Choice of Endocrine Therapy plus Everolimus

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

Geneesmiddel: 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.

Geneesmiddel: 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.

Geneesmiddel: 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.

Geneesmiddel: 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.

Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Totale overleving, in de ESR1m-subpopulatie en ITT-populatie
Tijdsspanne: Van randomisatie tot overlijden door welke oorzaak dan ook (tot 42 maanden)
Van randomisatie tot overlijden door welke oorzaak dan ook (tot 42 maanden)
Duur van respons (DOR), zoals bepaald door de onderzoeker volgens RECIST v1.1, in de ESR1m-subpopulatie en ITT-populatie
Tijdsspanne: Vanaf het eerste optreden van een gedocumenteerde objectieve reactie op ziekteprogressie of overlijden door welke oorzaak dan ook, afhankelijk van wat zich het eerst voordoet (tot 42 maanden)
Vanaf het eerste optreden van een gedocumenteerde objectieve reactie op ziekteprogressie of overlijden door welke oorzaak dan ook, afhankelijk van wat zich het eerst voordoet (tot 42 maanden)
Aantal deelnemers met ten minste één bijwerking, waarbij de ernst is bepaald volgens de Common Terminology Criteria for Adverse Events van het National Cancer Institute, versie 5 (NCI CTCAE v5.0)
Tijdsspanne: Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Aantal deelnemers met klinische laboratoriumtestafwijkingen voor hematologische parameters in de loop van het onderzoek
Tijdsspanne: Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Aantal deelnemers met klinische laboratoriumtestafwijkingen voor biochemische parameters in de loop van het onderzoek
Tijdsspanne: Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Vanaf baseline tot 30 dagen na de laatste dosis van de onderzoeksbehandeling (tot 42 maanden)
Plasmaconcentratie van Giredestrant op gespecificeerde tijdstippen
Tijdsspanne: Predosis en 3 uur postdosis op Dag 1 en 15 van Cyclus 1, en predosis op Dag 1 van Cyclus 2 en 3 (1 cyclus is 28 dagen)
Predosis en 3 uur postdosis op Dag 1 en 15 van Cyclus 1, en predosis op Dag 1 van Cyclus 2 en 3 (1 cyclus is 28 dagen)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Genentech, Inc.

Onderzoekers

  • Studie directeur: Clinical Trials, Genentech, Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 augustus 2022

Primaire voltooiing (Werkelijk)

16 juli 2025

Studie voltooiing (Geschat)

15 juni 2027

Studieregistratiedata

Eerst ingediend

23 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

23 maart 2022

Eerst geplaatst (Werkelijk)

1 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ML43171
  • 2022-000199-20 (EudraCT-nummer)
  • 2023-506821-12-00 (Register-ID: CTIS (EU))
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren