Sacituzumab Govitecan for Advanced Triple-Negative Breast Cancer
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Recruiting
Phase 1Phase 2Interventional Study
Triple Negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for
This trial is looking for adults with advanced triple-negative breast cancer who have received specific treatments. Participants will receive a study drug called sacituzumab govitecan and will be monitored for safety and response to the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have triple-negative breast cancer confirmed by a doctor
I have advanced breast cancer that cannot be surgically removed
I have not responded to or relapsed after at least one prior treatment (Phase 1)
I have not received any prior treatment for advanced breast cancer (Phase 2)
My tumors are PD-L1 negative or I cannot receive a specific treatment for them
I have measurable disease my doctor can see on scans
I am in good health according to my ECOG performance status
You may not be able to join if
I have received a topoisomerase 1 inhibitor in the past
I have had a specific treatment directed at Trop-2 in the past
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-fr…
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Trial Locations
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Eligibility Criteria
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 ref…
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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