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New combo aims to slow advanced breast cancer

NCT ID NCT05306340

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, giredestrant, combined with everolimus against standard hormone therapy plus everolimus in people with a common type of advanced breast cancer (ER+/HER2-). About 373 participants who have already tried other treatments will be enrolled. The goal is to see if the new combination can delay cancer growth and improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

373 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer

Contacts and locations

Locations

  • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

    Verona, Veneto, 37124, Italy

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • Abramson Cancer Center Chester County Hospital

    West Chester, Pennsylvania, 19380, United States

  • Agios Loucas Clinic SA

    Panórama, 552 36, Greece

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508, United States

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704, United States

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401, United States

  • Arizona Oncology Associates, PC-CASA

    Tucson, Arizona, 85711, United States

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162, Italy

  • Attikon University General Hospital

    Athens, 12464, Greece

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena, Emilia-Romagna, 41110, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, The Marches, 60126, Italy

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004, Spain

  • Centro Medico Privado CEMAIC

    Córdoba, X5008AAC, Argentina

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

    San Juan, J5402DIL, Argentina

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

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina

  • Centro de Investigación Clínica ? Clínica Viedma

    Viedma, R8500ACE, Argentina

  • Chang Gung Memorial Hospital

    Kaohsiung Country, 833, Taiwan

  • Chang Gung Memorial Hospital - Linkou Branch

    Taipei, Taiwan

  • Changhua Christian Hospital

    Chang-hua, 500, Taiwan

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

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

    A Coruña, LA Coruna, 15006, Spain

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP, Argentina

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dorset County Hospital

    Dorchester, DT1 2JY, United Kingdom

  • Eastern Maine Medical Center

    Brewer, Maine, 04412, United States

  • Fundacion Centro Oncologico de Integracion Regional (COIR)

    Mendoza, M5500AYB, Argentina

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Dexeus

    Barcelona, 08028, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008, Spain

  • Hospital Provincial del Centenario

    Rosario, S2002KDS, Argentina

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Hyogo Cancer Center

    Hyōgo, 673-0021, Japan

  • IASO Obstetrics Gynecology Clinic

    Marousi, 151 23, Greece

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    Genoa, Liguria, 16132, Italy

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031, United States

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ, Argentina

  • Instituto de Oncologia de Rosario

    Rosario, S2013KZE, Argentina

  • Instituto de Oncología Ángel H. Roffo

    Agronomía, Ciudad Autónoma de BuenosAires, C1417DTB, Argentina

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 546 39, Greece

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, Lazio, 00144, Italy

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • Kliniken Essen-Mitte

    Essen, 45136, Germany

  • Knappschaft Kliniken Marienhospital Bottrop

    Bottrop, 46236, Germany

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112, Taiwan

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017, United States

  • McGlinn Cancer Institute at Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196, South Africa

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Sloan Kettering - Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Metaxa Cancer Hospital of Piraeus

    Piraeus, 185 37, Greece

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416, United States

  • Metropolitan General Hospital

    Cholargós, 155 62, Greece

  • Millennium Research & Clinical Development

    Houston, Texas, 77090, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • Nagoya University Hospital

    Aichi, 466-8560, Japan

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • National Taiwan University Hospital

    Taipei, 100229, Taiwan

  • National University Hospital

    Singapore, 117599, Singapore

  • New England Cancer Specialists

    Scarborough, Maine, 04074, United States

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • North Middlesex Uni Hospital

    London, N18 1QX, United Kingdom

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146, United States

  • Olympion Clinic

    Pátrai, 264 43, Greece

  • Oncocare Cancer Centre

    Singapore, 258500, Singapore

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68103, United States

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO, Argentina

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Renown Regional Medical Center

    Reno, Nevada, 89502, United States

  • SAKARYA University Medical Faculty

    Sakarya, 811, Turkey (Türkiye)

  • SCRI Mark H. Zangmeister Center

    Columbus, Ohio, 43219, United States

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Scripps Health

    La Jolla, California, 92037, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722, South Korea

  • Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • Soon Chun Hyang University Cheonan Hospital

    Dongnam-gu, Cheonan-si, 31151, South Korea

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • St Charles Medical Center Bend

    Bend, Oregon, 97701, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Summit Cancer Care PC

    Savannah, Georgia, 31405, United States

  • TOI Clinical Research

    Cerritos, California, 90703, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Bedford, Texas, 76022, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology P.A.

    San Antonio, Texas, 78229, United States

  • Texas Oncology, P.A. - El Paso

    El Paso, Texas, 79902, United States

  • Texas Oncology-Denton South

    Denton, Texas, 76201, United States

  • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

    New York, New York, 10011, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Christie NHS Foundation Trust - SSC Parent

    Manchester, M20 4BX, United Kingdom

  • Tokai University Hospital

    Kanagawa, 259-1193, Japan

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

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101, Germany

  • Universitatsklinikum Erlangen

    Erlangen, 91054, Germany

  • University General Hospital of Heraklion

    Heraklio, 711 10, Greece

  • University General Hospital of Larissa

    Larissa, 412 21, Greece

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199, United States

  • University of Athens, Hematological Clinic,

    Athens, 115 27, Greece

  • University of California, Irvine Medical Center

    Orange, California, 92868, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Tsukuba Hospital

    Ibaraki, 305-8576, Japan

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • West Cancer Center

    Germantown, Tennessee, 38138, United States

  • Women's Cancer Care

    Fresno, California, 93710, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States