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En studie som utvärderar effektiviteten och säkerheten av Giredestrant Plus Everolimus jämfört med Exemestane Plus Everolimus hos deltagare med östrogenreceptorpositiv, HER2-negativ, lokalt avancerad eller metastaserad bröstcancer (evera bröstcancer)

30 oktober 2026 uppdaterad av: Genentech, Inc.

En fas III, randomiserad, öppen, multicenterstudie som utvärderar effektiviteten och säkerheten av Giredestrant Plus Everolimus jämfört med Exemestane Plus Everolimus hos patienter med östrogenreceptorpositiv, HER2-negativ, lokalt avancerad eller metastaserad bröstcancer

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

373

Fas

  • Fas 3

Utökad åtkomst

Tillgängligt utanför den kliniska prövningen. Se utökad åtkomstpost.

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Giredestrant plus Everolimus
Läkemedel: 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).

Andra namn:
  • GDC-9545
  • RO7197597
  • RG6171
Läkemedel: 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.

Läkemedel: 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.

Läkemedel: 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.
Aktiv komparator: Physician's Choice of Endocrine Therapy plus Everolimus

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

Läkemedel: 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.

Läkemedel: 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.

Läkemedel: 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.

Läkemedel: 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.

Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total överlevnad, i ESR1m-subpopulationen och ITT-populationen
Tidsram: Från randomisering till dödsfall oavsett orsak (upp till 42 månader)
Från randomisering till dödsfall oavsett orsak (upp till 42 månader)
Duration of Response (DOR), som fastställts av utredaren enligt RECIST v1.1, i ESR1m-subpopulationen och ITT-populationen
Tidsram: Från den första förekomsten av ett dokumenterat objektivt svar på sjukdomsprogression eller död av någon orsak, beroende på vilket som inträffar först (upp till 42 månader)
Från den första förekomsten av ett dokumenterat objektivt svar på sjukdomsprogression eller död av någon orsak, beroende på vilket som inträffar först (upp till 42 månader)
Antal deltagare med minst en biverkning, med svårighetsgrad fastställd enligt National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)
Tidsram: Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Antal deltagare med avvikelser från kliniska laboratorietest för hematologiska parametrar under studiens gång
Tidsram: Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Antal deltagare med avvikelser från kliniska laboratorietest för biokemiska parametrar under studiens gång
Tidsram: Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Från baslinjen till 30 dagar efter den sista dosen av studiebehandlingen (upp till 42 månader)
Plasmakoncentration av Giredestrant vid specificerade tidpunkter
Tidsram: Fördosering och 3 timmar efter dos på dag 1 och 15 av cykel 1, och fördos på dag 1 av cykel 2 och 3 (1 cykel är 28 dagar)
Fördosering och 3 timmar efter dos på dag 1 och 15 av cykel 1, och fördos på dag 1 av cykel 2 och 3 (1 cykel är 28 dagar)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Genentech, Inc.

Utredare

  • Studierektor: Clinical Trials, Genentech, Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 augusti 2022

Primärt slutförande (Faktisk)

16 juli 2025

Avslutad studie (Beräknad)

15 juni 2027

Studieregistreringsdatum

Först inskickad

23 mars 2022

Först inskickad som uppfyllde QC-kriterierna

23 mars 2022

Första postat (Faktisk)

1 april 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ML43171
  • 2022-000199-20 (EudraCT-nummer)
  • 2023-506821-12-00 (Registeridentifierare: CTIS (EU))
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera