A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer (MoonROSE)

October 22, 2026 updated by: Genentech, Inc.

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.

Participants from Study RGT-419B_01-101 (NCT05304962) who are experiencing clinical benefit with GDC-4198, as determined by the investigator, may enroll in this study and continue receiving GDC-4198 at their current dose level following closure of Study RGT-419B_01-101.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research SA
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
      • São Paulo, Brazil, 01323-001
        • Recruiting
        • Beneficencia Portuguesa de Sao Paulo
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital do Cancer de Pernambuco - HCP
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Recruiting
        • ONCOSITE Centro de Pesquisa Clínica Em Oncologia
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Recruiting
        • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
  • China
      • Fuzhou, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
      • Nanning, China, 530201
        • Recruiting
        • Guangxi Cancer Hospital of Guangxi Medical University
    • SD
      • Jinan, SD, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Recruiting
        • Fudan University Shanghai Cancer Center - Pudong Campus
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
  • France
      • Caen, France, 14076
        • Recruiting
        • Centre Francois Baclesse
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugene Marquis
    • Champagne-Ardenne
      • Reims, Champagne-Ardenne, France, 51100
        • Recruiting
        • Institut Jean Godinot
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitatsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Recruiting
        • Uniklinikum Heidelberg
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitatsklinikum Tubingen
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • KEM - Evang. Huyssens-Stiftung Essen-Huttrop
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Bologna_Policlinico S Orsola Malpighi-Via Albertoni
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Recruiting
        • Asst Papa Giovanni XXIII
      • Brescia, Lombardy, Italy, 25123
        • Recruiting
        • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 6591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 3722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center.
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 6273
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Beata Maria Ana
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO l?Hospitalet ? Hospital Duran i Reynals
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-2606
        • Recruiting
        • Clearview Cancer Institute - Huntsville
    • Arizona
      • Tucson, Arizona, United States, 85724-0001
        • Recruiting
        • University of Arizona Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope - Orange County Lennar Foundation Cancer Center
      • La Jolla, California, United States, 92093-1503
        • Recruiting
        • UC San Diego Moores Cancer Center
      • San Diego, California, United States, 92103-1911
        • Recruiting
        • University of California San Diego Medical Center
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family CCC
    • Colorado
      • Aurora, Colorado, United States, 80124-5316
        • Recruiting
        • University of Colorado Cancer Center
    • Florida
      • Miami, Florida, United States, 33136-1002
        • Recruiting
        • Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Winship Cancer Institute of Emory University
    • Illinois
      • Zion, Illinois, United States, 60099
        • Recruiting
        • City of Hope® Cancer Center Chicago
    • Maine
      • Detroit, Maine, United States, 48201-2013
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Maryland Oncology Hematology - Annapolis
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University Siteman Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901-1914
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • New York
      • East Patchogue, New York, United States, 11772
        • Recruiting
        • New York Cancer & Blood Specialists
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Einstein Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute
      • Winston-Salem, North Carolina, United States, 27103-3224
        • Recruiting
        • Novant Health Oncology Specialists
    • Ohio
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic Mercy Hospital
      • Cleveland, Ohio, United States, 44195-0001
        • Recruiting
        • Cleveland Clinic Taussig Cancer Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-2360
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania - Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213-3108
        • Recruiting
        • UPMC - Hillman Cancer Center
    • Tennessee
      • Mount Juliet, Tennessee, United States, 37122
        • Recruiting
        • Tennesse Oncology - Mt. Juliet Clinic
      • Nashville, Tennessee, United States, 37204-3609
        • Recruiting
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Dallas, Texas, United States, 75246-2003
        • Recruiting
        • Texas Oncology (Worth) - USOR
    • Utah
      • Salt Lake City, Utah, United States, 84013
        • Recruiting
        • University of Utah Huntsman Cancer Institute
    • Virginia
      • Norfolk, Virginia, United States, 23502-2800
        • Recruiting
        • Virginia Oncology Associates (Norfolk) - USOR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Current participant enrolled in Study RGT-419B_01-101 who is experiencing clinical benefit from GDC-4198, as determined by the investigator, at the time of consent and enrollment in this study.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase Ib: Dose-Finding Stage

Participants will receive GDC-4198 as monotherapy and in combination with giredestrant, 30 milligrams (mg), orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days). Participants from study RGT-419B_01-101 will continue receiving GDC-4198 at their current dose level following closure of study RGT-419B_01-101.
Drug: GDC-4198

GDC-4198 will be administered orally.

Other Names:
  • RGT-419B
  • RO7840734
Drug: Giredestrant

Giredestrant will be administered orally.

Other Names:
  • GDC-9545
  • RO7197597
Experimental: Phase II: Arm A

Participants will receive GDC-4198, higher dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
Drug: GDC-4198

GDC-4198 will be administered orally.

Other Names:
  • RGT-419B
  • RO7840734
Drug: Giredestrant

Giredestrant will be administered orally.

Other Names:
  • GDC-9545
  • RO7197597
Experimental: Phase II: Arm B

Participants will receive GDC-4198, lower dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
Drug: GDC-4198

GDC-4198 will be administered orally.

Other Names:
  • RGT-419B
  • RO7840734
Drug: Giredestrant

Giredestrant will be administered orally.

Other Names:
  • GDC-9545
  • RO7197597
Experimental: Phase II: Arm C

Participants will receive abemaciclib, 150 mg twice daily, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
Drug: Giredestrant

Giredestrant will be administered orally.

Other Names:
  • GDC-9545
  • RO7197597
Drug: Abemaciclib

Abemaciclib will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs)
Time Frame: From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
Phase II: Progression-free Survival (PFS)
Time Frame: Up to 36 months
Up to 36 months
Phase Ib: Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 36 months

Severity of AEs determined according to the CTCAE v5.0 grading scale
Up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase Ib: Objective Response Rate (ORR)
Time Frame: Up to 36 months
Up to 36 months
Phase Ib: Clinical Benefit Rate (CBR)
Time Frame: Up to 36 months
Up to 36 months
Phase II: ORR
Time Frame: Up to 36 months
Up to 36 months
Phase II: Duration of Response (DOR)
Time Frame: Up to 36 months
Up to 36 months
Phase II: CBR
Time Frame: Up to 36 months
Up to 36 months
Phase II: Overall Survival (OS)
Time Frame: Up to 36 months
Up to 36 months
Phase II: OS Rate at 6 Months and 12 Months
Time Frame: Month 6, Month 12
Month 6, Month 12
Phase II: PFS Rate at 6 Months and 12 Months
Time Frame: Month 6, Month 12
Month 6, Month 12
Phase II: Plasma Concentration of GDC-4198
Time Frame: Up to 36 months
Up to 36 months
Phase II: Recommended Dose of GDC-4198
Time Frame: Up to 36 months
Up to 36 months
Phase II: Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 36 months

Severity of AEs determined according to the CTCAE v5.0 grading scale
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche (China) Holding Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO46021
  • 2025-521128-31-00 (Ctis)
  • 2025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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