NCT05382299 · CITED IN SOURCE DOCUMENTS

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-04-06

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Key Inclusion Criteria: * Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) * Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity * Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue * Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence * Individuals presenting with de novo metastatic TNBC are eligible * Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Demonstrates adequate organ function * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception * Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease Key Exclusion Criteria: * Positive serum pregnancy test or women who are lactating * Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment * Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry * May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible * Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor * Active second malignancy * Active serious infection requiring antibiotics * Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
intervention Names
Drug: Sacituzumab Govitecan-hziy
label
Sacituzumab Govitecan-hziy (SG)
type
EXPERIMENTAL
description
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
intervention Names
Drug: Paclitaxel
Drug: nab-Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin
label
Treatment of Physician's Choice (TPC)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Sacituzumab Govitecan-hziy (SG)
description
Administered intravenously
name
Sacituzumab Govitecan-hziy
other Names
IMMU-132
Trodelvy™
GS-0132
type
DRUG
arm Group Labels
Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
Paclitaxel
type
DRUG
arm Group Labels
Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
nab-Paclitaxel
other Names
Abraxane®
type
DRUG
arm Group Labels
Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
Gemcitabine
type
DRUG
arm Group Labels
Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
Carboplatin
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 623
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
measure
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
time Frame
Randomization up to approximately 57 months

secondary Outcomes

description
OS is defined as the time from the date of randomization until death due to any cause.
measure
Overall Survival (OS)
time Frame
Randomization up to approximately 57 months
description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
measure
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
time Frame
Randomization up to approximately 57 months
description
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first).
measure
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
time Frame
Randomization up to approximately 57 months
description
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
measure
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
time Frame
Randomization up to approximately 57 months
measure
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
time Frame
First dose date up to approximately 57 months plus 30 days
measure
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
time Frame
First dose date up to approximately 57 months plus 30 days
description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
measure
Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).
time Frame
Randomization up to approximately 57 months
description
TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (≥ 10 points deterioration from baseline in the fatigue scale) or death.
measure
Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
time Frame
Randomization up to approximately 57 months

Full study description

brief Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Source references

references

citation
Cortes J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, Tokunaga E, Brufsky A, Park YH, Xu B, Hegg R, Oliveira M, Fabi A, Vaksman N, Valdez T, Zhang X, Lai C, Tolaney SM; ASCENT-03 Clinical Trial Investigators. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025 Nov 13;393(19):1912-1925. doi: 10.1056/NEJMoa2511734. Epub 2025 Oct 19.
pmid
41124233
type
DERIVED