Could a different dosing schedule improve breast cancer treatment?
NCT ID NCT06926920
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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Get notified about this study
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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.
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The places running it
16 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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John Flynn Private Hospital
RECRUITINGTugun, Queensland, 4224, Australia
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Los Angeles Cancer Network (LACN) - Good Sam
RECRUITINGLos Angeles, California, 90017, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITINGSeoul, 03722, South Korea
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Siteman Cancer Center
RECRUITINGSt Louis, Missouri, 63110, United States
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St. Vincent's Hospital - Kinghorn Cancer Center
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
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Sunshine Coast University Private Hospital
RECRUITINGBirtinya, Queensland, 4575, Australia
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Tennessee Oncology, PLLC
RECRUITINGNashville, Tennessee, 37203, United States
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Texas Oncology - DFW
RECRUITINGDallas, Texas, 75246, United States
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The University of Kansas Hospital
RECRUITINGWestwood, Kansas, 66205, United States
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Virginia Oncology Associates
RECRUITINGNorfolk, Virginia, 23502, United States
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West Cancer Centre
RECRUITINGGermantown, Tennessee, 38138, United States
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Winship Cancer Institute - Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Other studies related to the condition(s) this trial covers.
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- Unlocking TNBC survival: genetic clues from 3,648 women
- New drug targets Sugar-Coated proteins on cancer cells
- New antibody aims to preserve immune checkpoint while fighting cancer
- Blood test aims to track cancer treatment response in real time
- Off-the-Shelf immune cells target solid tumors