AzTrials
AzTrials

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast CancerPhase 3NCT05306340

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

A Phase 3 study testing Giredestrant, Exemestane and Fulvestrant in people with Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer, run by Genentech, Inc. at 136 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Giredestrant, Exemestane and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
373 participants
Where
136 sitesin 13 countries
Study dates
3 Aug 2022to 15 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally
  • Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing
  • 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.
Show all 9Show fewer
  • 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
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • 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

Who cannot join

  • 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.
  • Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
  • Prior chemotherapy for locally advanced unresectable or metastatic disease
  • 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
  • Treatment with any investigational therapy within 28 days prior to initiation of study treatment
  • Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
Show all 18Show fewer
  • 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
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  • Active cardiac disease or history of cardiac dysfunction
  • 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
  • Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
  • Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
  • Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization
  • 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
  • Known allergy or hypersensitivity to any of the study drugs or any of their excipients
  • For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists
  • Pregnant or breastfeeding

Trial locations and contacts

136 sites in 13 countries.

136 sites in 13 countries

United States55 sites

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Memorial Sloan Kettering - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Bedford, Texas, 76022

  • St Charles Medical Center Bend

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Eastern Maine Medical Center

    Brewer, Maine, 04412

  • TOI Clinical Research

    Cerritos, California, 90703

  • Northwestern University

    Chicago, Illinois, 60611

  • SCRI Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology-Denton South

    Denton, Texas, 76201

  • Texas Oncology, P.A. - El Paso

    El Paso, Texas, 79902

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Women's Cancer Care

    Fresno, California, 93710

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Millennium Research & Clinical Development

    Houston, Texas, 77090

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Scripps Health

    La Jolla, California, 92037

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68103

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • UPMC Hillman Cancer Center - Magee-Women?s Hospital

    Pittsburgh, Pennsylvania, 15213

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Texas Oncology P.A.

    San Antonio, Texas, 78229

  • Summit Cancer Care PC

    Savannah, Georgia, 31405

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Arizona Oncology Associates, PC-CASA

    Tucson, Arizona, 85711

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

  • Abramson Cancer Center Chester County Hospital

    West Chester, Pennsylvania, 19380

  • McGlinn Cancer Institute at Reading Hospital

    West Reading, Pennsylvania, 19611

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Japan17 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • Nagoya University Hospital

    Aichi, 466-8560

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Shikoku Cancer Center

    Ehime, 791-0280

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Hyogo Cancer Center

    Hyōgo, 673-0021

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Juntendo University Hospital

    Tokyo, 113-8431

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Argentina11 sites

  • Instituto de Oncología Ángel H. Roffo

    Agronomía, Ciudad Autónoma de BuenosAires, C1417DTB

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Centro Medico Privado CEMAIC

    Córdoba, Córdoba Province, X5008AAC

  • Fundacion Centro Oncologico de Integracion Regional (COIR)

    Mendoza, M5500AYB

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • Instituto de Oncologia de Rosario

    Rosario, S2013KZE

  • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

    San Juan, J5402DIL

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO

  • Centro de Investigación Clínica ? Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Greece10 sites

  • University of Athens, Hematological Clinic,

    Athens, 115 27

  • Attikon University General Hospital

    Athens, 12464

  • Metropolitan General Hospital

    Cholargós, 155 62

  • University General Hospital of Heraklion

    Heraklio, 711 10

  • University General Hospital of Larissa

    Larissa, 412 21

  • IASO Obstetrics Gynecology Clinic

    Marousi, 151 23

  • Agios Loucas Clinic SA

    Panórama, 552 36

  • Olympion Clinic

    Pátrai, 264 43

  • Metaxa Cancer Hospital of Piraeus

    Piraeus, 185 37

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 546 39

Other trials in Greece

Spain10 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

    A Coruña, LA CORUNA, 15006

  • Hospital Dexeus

    Barcelona, BARCELONA, 08028

  • Hospital Clinic de Barcelona

    Barcelona, BARCELONA, 08036

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, CORDOBA, 14004

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, Murcia, 30008

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

Other trials in Spain

South Korea7 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Soon Chun Hyang University Cheonan Hospital

    Dongnam-gu, Cheonan-si, 31151

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Italy6 sites

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    Genoa, Liguria, 16132

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena, Emilia-Romagna, 41110

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, Lazio, 00144

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, The Marches, 60126

  • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

    Verona, Veneto, 37124

Other trials in Italy

Taiwan6 sites

  • Changhua Christian Hospital

    Chang-hua, 500

  • Chang Gung Memorial Hospital

    Kaohsiung Country, 833

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 100229

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital - Linkou Branch

    Taipei

Other trials in Taiwan

Germany5 sites

  • Knappschaft Kliniken Marienhospital Bottrop

    Bottrop, 46236

  • Universitatsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

Other trials in Germany

United Kingdom4 sites

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • North Middlesex Uni Hospital

    London, N18 1QX

  • The Christie NHS Foundation Trust - SSC Parent

    Manchester, Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

Other trials in United Kingdom

Singapore2 sites

  • National University Hospital

    Singapore, 117599

  • Oncocare Cancer Centre

    Singapore, 258500

Other trials in Singapore

Turkey (Türkiye)2 sites

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • SAKARYA University Medical Faculty

    Sakarya, 811

Other trials in Turkey (Türkiye)

South Africa1 site

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

Other trials in South Africa

About this study

Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

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.

Being tested
Giredestrant, Exemestane, Fulvestrant, Tamoxifen, Everolimus
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GiredestrantDrug

    Also called GDC-9545, RO7197597, RG6171

    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).

  • ExemestaneDrug

    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.

  • FulvestrantDrug

    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.

  • TamoxifenDrug

    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.

  • EverolimusDrug

    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.

  • LHRH AgonistDrug

    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.

  • Dexamethasone Mouth RinseDrug

    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.

Study groups in NCT05306340
Study groupRoleWhat they receive
Giredestrant plus EverolimusExperimentalNot described
Receives: Drug: Giredestrant; Drug: Everolimus; Drug: LHRH Agonist; Drug: Dexamethasone Mouth Rinse
Physician's Choice of Endocrine Therapy plus EverolimusActive comparatorThe physician's choice of endocrine therapy is defined as either exemestane, fulvestrant, or tamoxifen.
Receives: Drug: Exemestane; Drug: Fulvestrant; Drug: Tamoxifen; Drug: Everolimus; Drug: LHRH Agonist; Drug: Dexamethasone Mouth Rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)

Secondary outcomes (14)

  1. Overall Survival, in the ESR1m Subpopulation and ITT Population

    Measured: From randomization until death from any cause (up to 42 months)

  2. Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

    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.

    Measured: From randomization until progressive disease or death (up to 42 months)

  3. Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 42 months)

  4. Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

    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.

    Measured: From Baseline until progressive disease or death (up to 42 months)

  5. 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

    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.

    Measured: From randomization until 90 days after treatment discontinuation (up to 42 months)

  6. 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

    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

    Measured: From randomization until 90 days after treatment discontinuation (up to 42 months)

  7. 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

    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

    Measured: From randomization until 90 days after treatment discontinuation (up to 42 months)

  8. 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

    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

    Measured: From randomization until 90 days after treatment discontinuation (up to 42 months)

  9. 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

    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

    Measured: From randomization until 90 days after treatment discontinuation (up to 42 months)

  10. Number of Participants with at Least One Adverse Event, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)

    Measured: From Baseline until 30 days after the final dose of study treatment (up to 42 months)

  11. Number of Participants with Vital Sign Abnormalities Over the Course of the Study

    Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.

    Measured: From Baseline until 30 days after the final dose of study treatment (up to 42 months)

  12. Number of Participants with Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study

    Measured: From Baseline until 30 days after the final dose of study treatment (up to 42 months)

  13. Number of Participants with Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study

    Measured: From Baseline until 30 days after the final dose of study treatment (up to 42 months)

  14. Plasma Concentration of Giredestrant at Specified Timepoints

    Measured: Predose and 3 hours postdose on Days 1 and 15 of Cycle 1, and predose on Day 1 of Cycles 2 and 3 (1 cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start3 Aug 2022
  3. Primary completion16 Jul 2025
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306340
Sponsor's protocol ID
ML43171
Other IDs
2022-000199-20, 2023-506821-12-00, 2023
Status last verified
Oct 2026
First submitted
23 Mar 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Mayer EL, Tolaney SM, Martin M, Vidal GA, Moscetti L, Jhaveri KL, Brufsky A, Gradishar WJ, Schneeweiss A, Niikura N, Favret A, Alfie M, Lee KS, Khan S, Feldman MB, Day BM, Lam LH, Darbonne WC, Shah MD, Griffiths KL, DiLallo G, Perez-Moreno PD, Rugo HS; evERA Breast Cancer Investigators. Giredestrant plus Everolimus in Advanced Breast Cancer. N Engl J Med. 2026 Oct 1;395(13):1285-1298. doi: 10.1056/NEJMoa2602457.

    PubMed 42814929

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Giredestrant, Exemestane and Fulvestrant in people with Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer, run by Genentech, Inc. at 136 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, Japan, Argentina, Greece, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population (time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05306340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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