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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05382299




Registration number
NCT05382299
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022

Titles & IDs
Public title
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
Scientific title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Secondary ID [1] 0 0
2021-005743-79
Secondary ID [2] 0 0
GS-US-592-6238
Universal Trial Number (UTN)
Trial acronym
ASCENT-03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
PD-L1 Negative 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 - Paclitaxel
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin

Experimental: Sacituzumab Govitecan-hziy (SG) - Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.

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


Treatment: Drugs: Sacituzumab Govitecan-hziy
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 57 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization up to approximately 57 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 57 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 57 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 57 months
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
First dose date up to approximately 57 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 approximately 57 months plus 30 days
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
Randomization up to approximately 57 months
Secondary outcome [8] 0 0
Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
Timepoint [8] 0 0
Randomization up to approximately 57 months

Eligibility
Key inclusion criteria
Key

* 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
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 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.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
540
Accrual to date
Final
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
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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
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
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2065 - St Leonards
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4101 - South Brisbane
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4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
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7000 - Hobart
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
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Mexico
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Zapopan
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
State/province [204] 0 0
Maastricht
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Netherlands
State/province [205] 0 0
Rotterdam
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Poland
State/province [206] 0 0
Gdansk
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Poland
State/province [207] 0 0
Gliwice
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Poland
State/province [208] 0 0
Opole
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Poland
State/province [209] 0 0
Poznan
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Poland
State/province [210] 0 0
Siedlce
Country [211] 0 0
Poland
State/province [211] 0 0
Warsaw
Country [212] 0 0
Poland
State/province [212] 0 0
Warszawa
Country [213] 0 0
Puerto Rico
State/province [213] 0 0
Ponce
Country [214] 0 0
Puerto Rico
State/province [214] 0 0
San Juan
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Romania
State/province [215] 0 0
Bucharest
Country [216] 0 0
Romania
State/province [216] 0 0
Cluj-Napoca
Country [217] 0 0
Romania
State/province [217] 0 0
Craiova
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Romania
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Timisoara
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Singapore
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Singapore
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Slovakia
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Bratislava
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Slovakia
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Košice
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Slovakia
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South Africa
State/province [223] 0 0
Hilton
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South Africa
State/province [224] 0 0
Johannesburg
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South Africa
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Pretoria
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Spain
State/province [226] 0 0
A Coruña
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Spain
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Barcelona
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Spain
State/province [228] 0 0
Bilbo
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Spain
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Lleida
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Spain
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Madrid
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Spain
State/province [231] 0 0
Malaga
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Spain
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Murcia
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Spain
State/province [233] 0 0
Sevilla
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Spain
State/province [234] 0 0
Tenerife
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Spain
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Valencia
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Switzerland
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Baden
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Switzerland
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Liestal
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Switzerland
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Changhua
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Taiwan
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Hualien City
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Turkey
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Adana
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Turkey
State/province [250] 0 0
Ankara
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Turkey
State/province [251] 0 0
Edirne
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Turkey
State/province [252] 0 0
Istanbul
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Turkey
State/province [253] 0 0
Izmir
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Turkey
State/province [254] 0 0
Sariyer
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Turkey
State/province [255] 0 0
Sisli
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United Kingdom
State/province [256] 0 0
Cheltenham
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Glasgow
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United Kingdom
State/province [258] 0 0
Leeds
Country [259] 0 0
United Kingdom
State/province [259] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05382299