NCT05382286 · CITED IN SOURCE DOCUMENTS

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab 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: 2025-09-18

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (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 with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. * Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. * Individuals presenting with de novo metastatic TNBC are eligible for this study. * TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. * Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Demonstrates adequate organ function * Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Individuals with 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 prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. * Individuals 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. * Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. * Have an active second malignancy. * Have active serious infection requiring antibiotics. * Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. 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 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
intervention Names
Drug: Sacituzumab Govitecan-hziy
Drug: Pembrolizumab
label
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
type
EXPERIMENTAL
description
Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles * nab-Paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
intervention Names
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: nab-Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin
label
Pembrolizumab + Treatment of Physician's Choice (TPC)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
description
Administered intravenously
name
Sacituzumab Govitecan-hziy
other Names
IMMU-132
Trodelvy™
GS-0132
type
DRUG
arm Group Labels
Pembrolizumab + Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
description
Administered intravenously
name
Pembrolizumab
other Names
KEYTRUDA®
type
DRUG
arm Group Labels
Pembrolizumab + Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
Paclitaxel
other Names
Taxol®
type
DRUG
arm Group Labels
Pembrolizumab + Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
nab-Paclitaxel
other Names
Abraxane®
type
DRUG
arm Group Labels
Pembrolizumab + Treatment of Physician's Choice (TPC)
description
Administered intravenously
name
Gemcitabine
other Names
Gemzar
type
DRUG
arm Group Labels
Pembrolizumab + 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: 443
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 33 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 53 months
description
ORR is defined as the proportion of participants who achieve 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 53 months
description
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective 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 53 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 53 months
measure
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
time Frame
First dose date up to 53 months plus 30 days
measure
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
time Frame
First dose date up to 53 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
measure
Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale 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 53 months
description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
measure
TTD of Pain Score as Measured by EORTC QLQ-C30
time Frame
Randomization up to approximately 53 months
description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
measure
TTD of Fatigue Score as Measured by EORTC QLQ-C30
time Frame
Randomization up to approximately 53 months
description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
measure
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
time Frame
Randomization up to approximately 53 months
description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
measure
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
time Frame
Randomization up to approximately 53 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) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Source references

references

citation
Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, Rapoport B, Im SA, Pistilli B, Mchayleh W, Cescon DW, Watanabe J, Banuelas MAL, Freitas-Junior R, Salvador Bofill J, Afshari M, Gary D, Wang L, Lai C, Schmid P; ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026 Jan 22;394(4):354-366. doi: 10.1056/NEJMoa2508959.
pmid
41564397
type
DERIVED