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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05633654
Registration number
NCT05633654
Ethics application status
Date submitted
21/11/2022
Date registered
1/12/2022
Date last updated
27/06/2025
Titles & IDs
Public title
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
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Scientific title
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
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Secondary ID [1]
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2024-512279-10
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Secondary ID [2]
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GS-US-595-6184
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab govitecan-hziy (SG)
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Capecitabine
Experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab - Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles.
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Active comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine - Participants will receive one of the following TPC regimens determined prior to randomization:
* Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR
* Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles.
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.
Treatment: Drugs: Sacituzumab govitecan-hziy (SG)
Administered intravenously
Treatment: Drugs: Pembrolizumab
Administered intravenously
Treatment: Drugs: Capecitabine
Tablets administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Invasive Disease-free Survival (iDFS)
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Assessment method [1]
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iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
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Timepoint [1]
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Up to 60 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization until death due to any cause.
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Timepoint [1]
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Up to 96 months
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Secondary outcome [2]
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Distant Disease-free Survival (dDFS)
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Assessment method [2]
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dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.
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Timepoint [2]
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Up to 60 months
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Secondary outcome [3]
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Recurrence-free Survival (RFS)
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Assessment method [3]
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RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.
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Timepoint [3]
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Up to 60 months
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Secondary outcome [4]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [4]
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Timepoint [4]
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First dose date up to 38 months plus 30 days
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Secondary outcome [5]
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Percentage of Participants Experiencing Laboratory Abnormalities
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Assessment method [5]
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Timepoint [5]
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First dose date up to 38 months plus 30 days
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Secondary outcome [6]
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Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores
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Assessment method [6]
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TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.
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Timepoint [6]
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Up to 60 months
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Eligibility
Key inclusion criteria
Key
* Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
* TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) = 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
* Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
* Adequate organ function.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
* Evidence of recurrent disease following preoperative therapy and surgery.
* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
* Individuals with germline breast cancer gene (BRCA) mutations.
* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
* Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2022
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Date of last participant enrolment
Anticipated
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Date of last data collection
Anticipated
1/08/2031
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Actual
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Sample size
Target
1514
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Macarthur Cancer Therapy Centre, Campbelltown Hospital - Campbelltown
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Lake Macquarie Private Hospital - Gateshead
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Monash Medical Centre - Clayton
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2560 - Campbelltown
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2290 - Gateshead
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3168 - Clayton
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Other
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Name [1]
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Alliance Foundation Trials, LLC.
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Other
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NSABP Foundation Inc
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GBG Forschungs GmbH
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Ethics approval
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Summary
Brief summary
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
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Trial website
https://clinicaltrials.gov/study/NCT05633654
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for public queries
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Gilead Clinical Study Information Center
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Phone
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1-833-445-3230 (GILEAD-0)
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT05633654
Download to PDF