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New hope for advanced breast cancer: experimental drug combo enters human trials

NCT ID NCT07100106

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 6 times

Summary

This study tests a new drug called GDC-4198, alone or combined with another drug (giredestrant), against a standard treatment (abemaciclib plus giredestrant) in people with advanced ER+/HER2- breast cancer that has worsened after prior CDK4/6 inhibitor therapy. The trial has two phases: first to check safety and dosing, then to compare how well the new combination controls the cancer. About 285 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GDC-4198 (also known as RGT-419B) and giredestrant (also known as GDC-9545)
What this could lead to
If successful, this could offer a new treatment option for people with advanced ER+/HER2- breast cancer whose disease has worsened after standard CDK4/6 inhibitor therapy.
What could go wrong
This is an early-phase (Ib/II) trial with only 285 participants, so results may not confirm benefit or safety. The new drug combination might not work better than existing treatments and could have unexpected side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Aug 2028

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: * Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic. * Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines. * Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting. * Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy \>= 6 months. Exclusion Criteria: * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines. * Have received more than one-line of therapy for locally advanced or metastatic disease. * Have received prior chemotherapy for metastatic breast cancer. * Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug. * Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption * History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death. * Known allergy or hypersensitivity to any component of the study treatments.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    64 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    RECRUITING

    Brescia, Lombardy, 25123, Italy

  • Asan Medical Center.

    RECRUITING

    Seoul, 05505, South Korea

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Detroit, Maine, 48201-2013, United States

  • Cancer Research SA

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Centre Eugene Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope - Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope® Cancer Center Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • Fudan University Shanghai Cancer Center - Pudong Campus

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 6273, South Korea

  • Guangxi Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, 530201, China

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • Hospital Beata Maria Ana

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

  • Hospital do Cancer de Pernambuco - HCP

    RECRUITING

    Recife, Pernambuco, 50040-000, Brazil

  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Institut Jean Godinot

    RECRUITING

    Reims, Champagne-Ardenne, 51100, France

  • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    RECRUITING

    Barcelona, 08035, Spain

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • KEM - Evang. Huyssens-Stiftung Essen-Huttrop

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Maryland Oncology Hematology - Annapolis

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Einstein Cancer Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • New York Cancer & Blood Specialists

    RECRUITING

    East Patchogue, New York, 11772, United States

  • Novant Health Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Novant Health Oncology Specialists

    RECRUITING

    Winston-Salem, North Carolina, 27103-3224, United States

  • ONCOSITE Centro de Pesquisa Clínica Em Oncologia

    RECRUITING

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

  • Oncology Associates of Oregon, P.C

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Ospedale San Raffaele S.r.l. - PPDS

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Penn State Health Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033-2360, United States

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901-1914, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, SD, 250117, China

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136-1002, United States

  • Texas Oncology (Worth) - USOR

    RECRUITING

    Dallas, Texas, 75246-2003, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    RECRUITING

    Seoul, 6591, South Korea

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093-1503, United States

  • UCSF Helen Diller Family CCC

    RECRUITING

    San Francisco, California, 94158, United States

  • UPMC - Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213-3108, United States

  • Universitatsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • Universitatsklinikum Tubingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724-0001, United States

  • University of California San Diego Medical Center

    RECRUITING

    San Diego, California, 92103-1911, United States

  • University of Pennsylvania - Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84013, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    RECRUITING

    Nashville, Tennessee, 37204-3609, United States

  • Virginia Oncology Associates (Norfolk) - USOR

    RECRUITING

    Norfolk, Virginia, 23502-2800, United States

  • Washington University Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

More trials for these conditions

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