Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a different dosing schedule improve breast cancer treatment?

NCT ID NCT06926920

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a different dose and schedule of the drug sacituzumab govitecan (Trodelvy) in people with advanced triple-negative breast cancer that has not responded to prior treatment. The trial has two phases: phase 1 checks safety and the best dose, and phase 2 measures how well the drug shrinks tumors and delays cancer growth. About 100 adults with this type of breast cancer will take part.

What this could mean

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

Active substance
sacituzumab govitecan (Trodelvy)
What this could lead to
If successful, this could offer a more effective or better-tolerated dosing option for people with advanced triple-negative breast cancer.
What could go wrong
This is an early-phase trial (phase 1/2) with only 100 participants, so results may not apply broadly. The drug can cause side effects like nausea, fatigue, and low blood cell counts.

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 100 people

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

Started

Apr 2025

Expected to finish

Jun 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.

Key Inclusion Criteria: * Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent. * Histologically or cytologically locally confirmed TNBC. * Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease. * Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease. * Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \< 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity. * Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status. During Phase 1 safety run-in, individuals must be UGT1A1 wild-type. After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate hematologic counts within 2 weeks prior to enrollment. * Adequate hepatic and renal function. Key Exclusion Criteria: * Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor. * Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. Note: Other protocol defined Inclusion/Exclusion criteria will apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Triple-negative breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    16 sites in 3 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

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • John Flynn Private Hospital

    RECRUITING

    Tugun, Queensland, 4224, Australia

  • Los Angeles Cancer Network (LACN) - Good Sam

    RECRUITING

    Los Angeles, California, 90017, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    NOT_YET_RECRUITING

    Seoul, 03722, South Korea

  • Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • St. Vincent's Hospital - Kinghorn Cancer Center

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • Tennessee Oncology, PLLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - DFW

    RECRUITING

    Dallas, Texas, 75246, United States

  • The University of Kansas Hospital

    RECRUITING

    Westwood, Kansas, 66205, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • West Cancer Centre

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Winship Cancer Institute - Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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