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New hope for advanced breast cancer: giredestrant trial shows promise

NCT ID NCT04576455

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study tests a new drug called giredestrant in people with a type of advanced breast cancer (ER-positive, HER2-negative) that has progressed after prior treatments. About 303 participants will receive either giredestrant or another standard hormone therapy chosen by their doctor. The goal is to see if giredestrant can delay cancer growth better than current options.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

303 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Aug 2027

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: * Women who are postmenopausal or premenopausal/perimenopausal * For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment * Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * Documented ER-positive tumor and HER2-negative tumor, assessed locally * Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting * Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization * Treatment with any investigational therapy within 28 days prior to randomization * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications * Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Active cardiac disease or history of cardiac dysfunction * 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-positive, HER2-negative, locally advanced or metastatic breast cancer

Contacts and locations

Locations

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Assuta Medical Center- Ashdod

    Ashdod, Israel

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027, Poland

  • Blokhin Cancer Research Center

    Moskva, Moscow Oblast, 115478, Russia

  • Chang Gung Memorial Hosipital at Linkou

    Taoyuan Hsien, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chi-Mei Medical Centre

    Tainan, 710, Taiwan

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001, Brazil

  • Clinical Oncology Centre # 1

    Krasnodar, 350040, Russia

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280, Turkey (Türkiye)

  • Eastleigh Breast Care Centre

    Pretoria, 0081, South Africa

  • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

    Nizhny Novgorod, Niznij Novgorod, 603081, Russia

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

    Berlin, 14169, Germany

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD, Argentina

  • Fundación Scherbovsky

    Mendoza, M5500AYB, Argentina

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Guys & St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Gynäkologie Kompetenzzentrum

    Stralsund, 18439, Germany

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112000, Israel

  • Hosp Provincial D. Centenarios

    Rosario, S2002KDS, Argentina

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

    Aschaffenburg, 63739, Germany

  • Iatros International

    Bloemfontein, 9301, South Africa

  • Instituto Angel Roffo

    Buenos Aires, 1417, Argentina

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360, Turkey (Türkiye)

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi

    Istanbul, 34000, Turkey (Türkiye)

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010, Australia

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357, Germany

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133, Russia

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Linyishi Cancer Hospital

    Linyi, 276034, China

  • MI Kyiv Regional Council Kyiv Regional Oncological Dispensary

    Kyiv, 04107, Ukraine

  • Maharaj Nakorn Chiang Mai Hosp

    Chang Mai, 50200, Thailand

  • Medikal Park Samsun

    Samsun, 55200, Turkey (Türkiye)

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Antalya Hospital

    Antalya, 07020, Turkey (Türkiye)

  • Multidisciplinary clinic Reaviz

    Samara, 443011, Russia

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

    Warsaw, 02-781, Poland

  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Gliwice, 44-102, Poland

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Centre

    Singapore, 169610, Singapore

  • National Cheng Kung Uni Hospital

    Tainan, 704, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • Northwest Cancer Specialists - Portland (SW Barnes Rd)

    Tigard, Oregon, 97223, United States

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO, Argentina

  • Peterborough City Hospital

    Peterborough, PE3 9GZ, United Kingdom

  • Petrov Research Inst. of Oncology

    Pesochny, Leningrad, 197758, Russia

  • Princess Alexandra Hospital

    Harlow, CM20 1QX, United Kingdom

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, 34384, Turkey (Türkiye)

  • Pronutrir - suporte nutricional e quimioterapia ltda.

    Fortaleza, Ceará, 60810-180, Brazil

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005, Ukraine

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040, Russia

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan', Tatarstan Republic, 420029, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Soon Chun Hyang University Cheonan Hospital

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

  • St. Petersburg SHI "City Clinical Oncology Dispensary"

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • St. Vincenz-Krankenhaus Paderborn

    Paderborn, 33098, Germany

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Third Hospital of Nanchang

    Nanchang, 330000, China

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • Veterans General Hospital

    Taipei, 00112, Taiwan

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138, Russia

  • Zhejiang Cancer Hospital

    Zhejiang, 310022, China

  • Zhytomyr Regional Oncology Center

    Zhytomyr, KIEV Governorate, Ukraine

More trials for these conditions

Other studies related to the condition(s) this trial covers.