Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05382286




Registration number
NCT05382286
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Date last updated
26/11/2024

Titles & IDs
Public title
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
Scientific title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Secondary ID [1] 0 0
2021-005742-14
Secondary ID [2] 0 0
GS-US-592-6173
Universal Trial Number (UTN)
Trial acronym
ASCENT-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
PD-L1 Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin

Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab - 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.

Active comparator: Pembrolizumab + Treatment of Physician's Choice (TPC) - 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


Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously

Treatment: Drugs: Pembrolizumab
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: nab-Paclitaxel
Administered intravenously

Treatment: Drugs: Gemcitabine
Administered intravenously

Treatment: Drugs: Carboplatin
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
Randomization up to approximately 33 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization up to approximately 53 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Timepoint [2] 0 0
Randomization up to approximately 53 months
Secondary outcome [3] 0 0
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Timepoint [3] 0 0
Randomization up to approximately 53 months
Secondary outcome [4] 0 0
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Timepoint [4] 0 0
Randomization up to approximately 53 months
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
First dose date up to 53 months plus 30 days
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timepoint [6] 0 0
First dose date up to 53 months plus 30 days
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Randomization up to approximately 53 months
Secondary outcome [8] 0 0
TTD of Pain Score as Measured by EORTC QLQ-C30
Timepoint [8] 0 0
Randomization up to approximately 53 months
Secondary outcome [9] 0 0
TTD of Fatigue Score as Measured by EORTC QLQ-C30
Timepoint [9] 0 0
Randomization up to approximately 53 months
Secondary outcome [10] 0 0
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
Timepoint [10] 0 0
Randomization up to approximately 53 months
Secondary outcome [11] 0 0
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
Timepoint [11] 0 0
Randomization up to approximately 53 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
Accrual to date
Final
443
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Saint George Hospital - Australia - Kogarah
Recruitment hospital [3] 0 0
Mater Hospital - North Sydney - North Sydney
Recruitment hospital [4] 0 0
GenesisCare - North Shore - St Leonards
Recruitment hospital [5] 0 0
Mater Misericordiae Limited and Mater Research Limited - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Cancer Research SA (CRSA) - Adelaide
Recruitment hospital [8] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Hospital - Melbourne
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Parkville
Recruitment hospital [12] 0 0
Breast Cancer Research Center - Western Australia - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Caba
Country [35] 0 0
Argentina
State/province [35] 0 0
Capital
Country [36] 0 0
Argentina
State/province [36] 0 0
Rosario
Country [37] 0 0
Argentina
State/province [37] 0 0
San Miguel de Tucumán
Country [38] 0 0
Argentina
State/province [38] 0 0
Viedma
Country [39] 0 0
Austria
State/province [39] 0 0
Innsbruck
Country [40] 0 0
Austria
State/province [40] 0 0
Linz
Country [41] 0 0
Austria
State/province [41] 0 0
Salzburg
Country [42] 0 0
Austria
State/province [42] 0 0
Sankt Poelten
Country [43] 0 0
Austria
State/province [43] 0 0
Wien
Country [44] 0 0
Belgium
State/province [44] 0 0
Anderlecht
Country [45] 0 0
Belgium
State/province [45] 0 0
Brasschaat
Country [46] 0 0
Belgium
State/province [46] 0 0
Brussels
Country [47] 0 0
Belgium
State/province [47] 0 0
Charleroi
Country [48] 0 0
Belgium
State/province [48] 0 0
Gent
Country [49] 0 0
Belgium
State/province [49] 0 0
Leuven
Country [50] 0 0
Belgium
State/province [50] 0 0
Namur
Country [51] 0 0
Brazil
State/province [51] 0 0
Goiânia
Country [52] 0 0
Brazil
State/province [52] 0 0
Ijui
Country [53] 0 0
Brazil
State/province [53] 0 0
Itajai
Country [54] 0 0
Brazil
State/province [54] 0 0
Jau
Country [55] 0 0
Brazil
State/province [55] 0 0
Porto Alegre
Country [56] 0 0
Brazil
State/province [56] 0 0
Rio de Janeiro
Country [57] 0 0
Brazil
State/province [57] 0 0
Salvador
Country [58] 0 0
Brazil
State/province [58] 0 0
Santo Andre
Country [59] 0 0
Brazil
State/province [59] 0 0
São Paulo
Country [60] 0 0
Canada
State/province [60] 0 0
Calgary
Country [61] 0 0
Canada
State/province [61] 0 0
Edmonton
Country [62] 0 0
Canada
State/province [62] 0 0
Halifax
Country [63] 0 0
Canada
State/province [63] 0 0
Kitchener
Country [64] 0 0
Canada
State/province [64] 0 0
London
Country [65] 0 0
Canada
State/province [65] 0 0
Montreal
Country [66] 0 0
Canada
State/province [66] 0 0
Montréal
Country [67] 0 0
Canada
State/province [67] 0 0
Ontario
Country [68] 0 0
Canada
State/province [68] 0 0
Ottawa
Country [69] 0 0
Canada
State/province [69] 0 0
Toronto
Country [70] 0 0
Canada
State/province [70] 0 0
Vancouver
Country [71] 0 0
Chile
State/province [71] 0 0
Providencia
Country [72] 0 0
Chile
State/province [72] 0 0
Santiago DE CHILE
Country [73] 0 0
Chile
State/province [73] 0 0
Santiago Region
Country [74] 0 0
Chile
State/province [74] 0 0
Santiago
Country [75] 0 0
Chile
State/province [75] 0 0
Temuco
Country [76] 0 0
Czechia
State/province [76] 0 0
Brno
Country [77] 0 0
Czechia
State/province [77] 0 0
Hradec Kralove
Country [78] 0 0
Czechia
State/province [78] 0 0
Hradec Králové
Country [79] 0 0
Czechia
State/province [79] 0 0
Olomouc
Country [80] 0 0
Czechia
State/province [80] 0 0
Prague
Country [81] 0 0
Czechia
State/province [81] 0 0
Praha
Country [82] 0 0
France
State/province [82] 0 0
Avignon
Country [83] 0 0
France
State/province [83] 0 0
Besancon
Country [84] 0 0
France
State/province [84] 0 0
Bordeaux
Country [85] 0 0
France
State/province [85] 0 0
Brest
Country [86] 0 0
France
State/province [86] 0 0
Caen
Country [87] 0 0
France
State/province [87] 0 0
Clermont Ferrand
Country [88] 0 0
France
State/province [88] 0 0
Lyon
Country [89] 0 0
France
State/province [89] 0 0
Marseille CEDEX 9
Country [90] 0 0
France
State/province [90] 0 0
Montpellier Cedex 5
Country [91] 0 0
France
State/province [91] 0 0
Montpellier
Country [92] 0 0
France
State/province [92] 0 0
Nantes
Country [93] 0 0
France
State/province [93] 0 0
Pierre-Benite
Country [94] 0 0
France
State/province [94] 0 0
Plerin
Country [95] 0 0
France
State/province [95] 0 0
Rennes Cedex
Country [96] 0 0
France
State/province [96] 0 0
Toulouse
Country [97] 0 0
France
State/province [97] 0 0
Villejuif
Country [98] 0 0
Germany
State/province [98] 0 0
Berlin
Country [99] 0 0
Germany
State/province [99] 0 0
Bonn
Country [100] 0 0
Germany
State/province [100] 0 0
Bottrop
Country [101] 0 0
Germany
State/province [101] 0 0
Erlangen
Country [102] 0 0
Germany
State/province [102] 0 0
Essen
Country [103] 0 0
Germany
State/province [103] 0 0
Freiburg
Country [104] 0 0
Germany
State/province [104] 0 0
Hamburg
Country [105] 0 0
Germany
State/province [105] 0 0
Heidelberg
Country [106] 0 0
Germany
State/province [106] 0 0
Köln
Country [107] 0 0
Germany
State/province [107] 0 0
Lübeck
Country [108] 0 0
Germany
State/province [108] 0 0
Mannheim
Country [109] 0 0
Germany
State/province [109] 0 0
Munster
Country [110] 0 0
Germany
State/province [110] 0 0
Mönchengladbach
Country [111] 0 0
Germany
State/province [111] 0 0
München
Country [112] 0 0
Germany
State/province [112] 0 0
Tübingen
Country [113] 0 0
Germany
State/province [113] 0 0
Wiesbaden
Country [114] 0 0
Hong Kong
State/province [114] 0 0
Hong Kong
Country [115] 0 0
Hong Kong
State/province [115] 0 0
New Territories
Country [116] 0 0
Hungary
State/province [116] 0 0
Budapest
Country [117] 0 0
Hungary
State/province [117] 0 0
Debrecen
Country [118] 0 0
Hungary
State/province [118] 0 0
Gyor
Country [119] 0 0
Israel
State/province [119] 0 0
Beer-Sheva
Country [120] 0 0
Israel
State/province [120] 0 0
Haifa
Country [121] 0 0
Israel
State/province [121] 0 0
Jerusalem
Country [122] 0 0
Israel
State/province [122] 0 0
Kfar Saba
Country [123] 0 0
Israel
State/province [123] 0 0
Petah Tikva
Country [124] 0 0
Israel
State/province [124] 0 0
Rehovot
Country [125] 0 0
Israel
State/province [125] 0 0
Tel Aviv
Country [126] 0 0
Italy
State/province [126] 0 0
Bari
Country [127] 0 0
Italy
State/province [127] 0 0
Bologna
Country [128] 0 0
Italy
State/province [128] 0 0
Brescia
Country [129] 0 0
Italy
State/province [129] 0 0
Genova GE
Country [130] 0 0
Italy
State/province [130] 0 0
Lecco
Country [131] 0 0
Italy
State/province [131] 0 0
Lucca
Country [132] 0 0
Italy
State/province [132] 0 0
Macerata
Country [133] 0 0
Italy
State/province [133] 0 0
Milano
Country [134] 0 0
Italy
State/province [134] 0 0
Milan
Country [135] 0 0
Italy
State/province [135] 0 0
Monza
Country [136] 0 0
Italy
State/province [136] 0 0
Napoli
Country [137] 0 0
Italy
State/province [137] 0 0
Novara
Country [138] 0 0
Italy
State/province [138] 0 0
Padova
Country [139] 0 0
Italy
State/province [139] 0 0
Prato
Country [140] 0 0
Italy
State/province [140] 0 0
Roma
Country [141] 0 0
Italy
State/province [141] 0 0
Rome
Country [142] 0 0
Italy
State/province [142] 0 0
Siena
Country [143] 0 0
Japan
State/province [143] 0 0
Aichi
Country [144] 0 0
Japan
State/province [144] 0 0
Aoba-ku
Country [145] 0 0
Japan
State/province [145] 0 0
Bunkyo-ku
Country [146] 0 0
Japan
State/province [146] 0 0
Chuo-ku
Country [147] 0 0
Japan
State/province [147] 0 0
Ehime
Country [148] 0 0
Japan
State/province [148] 0 0
Fukushima
Country [149] 0 0
Japan
State/province [149] 0 0
Inamachi
Country [150] 0 0
Japan
State/province [150] 0 0
Kagoshima-shi
Country [151] 0 0
Japan
State/province [151] 0 0
Kanagawa
Country [152] 0 0
Japan
State/province [152] 0 0
Kashiwa
Country [153] 0 0
Japan
State/province [153] 0 0
Koto-ku
Country [154] 0 0
Japan
State/province [154] 0 0
Kumamoto- shi
Country [155] 0 0
Japan
State/province [155] 0 0
Kure
Country [156] 0 0
Japan
State/province [156] 0 0
Mie
Country [157] 0 0
Japan
State/province [157] 0 0
Nagoya
Country [158] 0 0
Japan
State/province [158] 0 0
Naka-ku
Country [159] 0 0
Japan
State/province [159] 0 0
Niigata-shi
Country [160] 0 0
Japan
State/province [160] 0 0
Okayama
Country [161] 0 0
Japan
State/province [161] 0 0
Ota
Country [162] 0 0
Japan
State/province [162] 0 0
Sakyo-ku
Country [163] 0 0
Japan
State/province [163] 0 0
Sapporo
Country [164] 0 0
Japan
State/province [164] 0 0
Shizuoka-city
Country [165] 0 0
Japan
State/province [165] 0 0
Shizuoka
Country [166] 0 0
Japan
State/province [166] 0 0
Suita
Country [167] 0 0
Japan
State/province [167] 0 0
Tokyo
Country [168] 0 0
Japan
State/province [168] 0 0
Yokohama
Country [169] 0 0
Korea, Republic of
State/province [169] 0 0
Goyang-si Gyeonggi-do
Country [170] 0 0
Korea, Republic of
State/province [170] 0 0
Seongnam-si
Country [171] 0 0
Korea, Republic of
State/province [171] 0 0
Seoul
Country [172] 0 0
Malaysia
State/province [172] 0 0
Georgetown
Country [173] 0 0
Malaysia
State/province [173] 0 0
Johor Bahru
Country [174] 0 0
Malaysia
State/province [174] 0 0
Kuala Lumpur
Country [175] 0 0
Malaysia
State/province [175] 0 0
Putrajaya
Country [176] 0 0
Malaysia
State/province [176] 0 0
Sabah
Country [177] 0 0
Malaysia
State/province [177] 0 0
Sarawak
Country [178] 0 0
Mexico
State/province [178] 0 0
Chihuahua
Country [179] 0 0
Mexico
State/province [179] 0 0
Ciudad de Mexico
Country [180] 0 0
Mexico
State/province [180] 0 0
Culiacan
Country [181] 0 0
Mexico
State/province [181] 0 0
Guadalajara
Country [182] 0 0
Mexico
State/province [182] 0 0
Merida
Country [183] 0 0
Mexico
State/province [183] 0 0
Monterrey
Country [184] 0 0
Mexico
State/province [184] 0 0
México
Country [185] 0 0
Mexico
State/province [185] 0 0
San Luis Potosi
Country [186] 0 0
Mexico
State/province [186] 0 0
Veracruz
Country [187] 0 0
Mexico
State/province [187] 0 0
Zapopan
Country [188] 0 0
Netherlands
State/province [188] 0 0
Breda
Country [189] 0 0
Netherlands
State/province [189] 0 0
Groningen
Country [190] 0 0
Netherlands
State/province [190] 0 0
Leeuwarden
Country [191] 0 0
Netherlands
State/province [191] 0 0
Rotterdam
Country [192] 0 0
Poland
State/province [192] 0 0
Gdansk
Country [193] 0 0
Poland
State/province [193] 0 0
Gliwice
Country [194] 0 0
Poland
State/province [194] 0 0
Opole
Country [195] 0 0
Poland
State/province [195] 0 0
Poznan
Country [196] 0 0
Poland
State/province [196] 0 0
Siedlce
Country [197] 0 0
Poland
State/province [197] 0 0
Warsaw
Country [198] 0 0
Poland
State/province [198] 0 0
Warszawa
Country [199] 0 0
Puerto Rico
State/province [199] 0 0
Ponce
Country [200] 0 0
South Africa
State/province [200] 0 0
Hilton
Country [201] 0 0
South Africa
State/province [201] 0 0
Johannesburg
Country [202] 0 0
South Africa
State/province [202] 0 0
Pretoria
Country [203] 0 0
Spain
State/province [203] 0 0
A Coruña
Country [204] 0 0
Spain
State/province [204] 0 0
Barcelona
Country [205] 0 0
Spain
State/province [205] 0 0
Bilbo
Country [206] 0 0
Spain
State/province [206] 0 0
Lleida
Country [207] 0 0
Spain
State/province [207] 0 0
Madrid
Country [208] 0 0
Spain
State/province [208] 0 0
Malaga
Country [209] 0 0
Spain
State/province [209] 0 0
Murcia
Country [210] 0 0
Spain
State/province [210] 0 0
Sevilla
Country [211] 0 0
Spain
State/province [211] 0 0
Tenerife
Country [212] 0 0
Spain
State/province [212] 0 0
Valencia
Country [213] 0 0
Switzerland
State/province [213] 0 0
Baden
Country [214] 0 0
Switzerland
State/province [214] 0 0
Liestal
Country [215] 0 0
Switzerland
State/province [215] 0 0
St. Gallen
Country [216] 0 0
Switzerland
State/province [216] 0 0
Winterthur
Country [217] 0 0
Switzerland
State/province [217] 0 0
Zürich
Country [218] 0 0
Taiwan
State/province [218] 0 0
Changhua
Country [219] 0 0
Taiwan
State/province [219] 0 0
Kaohsiung
Country [220] 0 0
Taiwan
State/province [220] 0 0
New Taipei City
Country [221] 0 0
Taiwan
State/province [221] 0 0
Tainan City
Country [222] 0 0
Taiwan
State/province [222] 0 0
Tainan
Country [223] 0 0
Taiwan
State/province [223] 0 0
Taipei City
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taipei
Country [225] 0 0
Taiwan
State/province [225] 0 0
Taoyuan
Country [226] 0 0
Turkey
State/province [226] 0 0
Adana
Country [227] 0 0
Turkey
State/province [227] 0 0
Ankara
Country [228] 0 0
Turkey
State/province [228] 0 0
Edirne
Country [229] 0 0
Turkey
State/province [229] 0 0
Istanbul
Country [230] 0 0
Turkey
State/province [230] 0 0
Izmir
Country [231] 0 0
Turkey
State/province [231] 0 0
Sariyer
Country [232] 0 0
Turkey
State/province [232] 0 0
Sisli
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Edinburgh
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Glasgow
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Leeds
Country [236] 0 0
United Kingdom
State/province [236] 0 0
London
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05382286
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05382286