NCT05633654ClinicalTrials.gov

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)

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 1,514 משתתפים372 אתרים11 מדינות

קטגוריות

אונקולוגיה81%רפואת עור19%

רשום במרשם אחד

ClinicalTrials.govNCT05633654פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני שבועיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-12-01; recorded start 2022-12-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 162 other studies in this databaseCounted from the lead sponsor named in the record (Gilead Sciences)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 356 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,514 participants (target), run at 372 sites, across 11 countries.

How this score is built

Enrolment32/40
1,514 participants (target)
Site count25/25
356 sites
Country count12/15
11 countries
Planned duration10/10
Planned over about 105 months
Sponsor scale9/10
Gilead Sciences has led 164 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

מצבים רפואיים

Triple Negative Breast Cancer

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Key Inclusion Criteria: * 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 aligned with local/institutional practice and have recovered prior to starting study treatment. * Adequate organ function. 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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 1,514 משתתפים

נותן חסות ושותפים

Gilead Sciences נותן חסות
Alliance Foundation Trials, LLC. שותפים
NSABP Foundation Inc שותפים
GBG Forschungs GmbH שותפים

זרועות והתערבויות

Sacituzumab govitecan-hziy (SG) + PembrolizumabEXPERIMENTAL
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.
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + CapecitabineACTIVE_COMPARATOR
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.

התערבויות

תרופה Capecitabine
Tablets administered orally
תרופה Pembrolizumab
Administered intravenously
תרופה Sacituzumab govitecan-hziy (SG)
Administered intravenously

מדדי תוצאה

מדד תוצאה ראשוני
Invasive Disease-free Survival (iDFS)
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.
מסגרת זמן Up to 60 months
מדד תוצאה משני
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
מסגרת זמן Up to 96 months
מדד תוצאה משני
Distant Disease-free Survival (dDFS)
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.
מסגרת זמן Up to 60 months
מדד תוצאה משני
Recurrence-free Survival (RFS)
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.
מסגרת זמן Up to 60 months
מדד תוצאה משני
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
מסגרת זמן First dose date up to 38 months plus 30 days
מדד תוצאה משני
Percentage of Participants Experiencing Laboratory Abnormalities
מסגרת זמן First dose date up to 38 months plus 30 days
מדד תוצאה משני
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
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.
מסגרת זמן Up to 60 months

תאריכים

תאריכים
תאריך התחלה	12 בדצמבר 2022 (בפועל)
סיום ראשוני	1 ביוני 2027 (משוער)
סיום	1 באוגוסט 2031 (משוער)
פורסם לראשונה	1 בדצמבר 2022 (בפועל)
עודכן לאחרונה	9 בספטמבר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	ספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

278 אתרים מגייסים

Australia

Australia
מתקן	עיר	מדינה או אזור	מצב
Cancer Research SA	Adelaide	South Australia	מגייס
Bendigo Health	Bendigo	Victoria	מגייס
Cairns Hospital	Cairns	Queensland	מגייס
Macarthur Cancer Therapy Centre, Campbelltown Hospital	Campbelltown	New South Wales	מגייס
Monash Medical Centre	Clayton	Victoria	מגייס
Kinghorn Cancer Centre	Darlinghurst	New South Wales	מגייס
Townsville University Hospital	Douglass	Queensland	מגייס
Lake Macquarie Private Hospital	Gateshead	New South Wales	מגייס
Fiona Stanley Hospital	Murdoch	Western Australia	מגייס
Port Macquarie Base Hospital	Port Macquarie	New South Wales	מגייס
Princess Alexandra Hospital	Woolloongabba	Queensland	מגייס

Belgium

Belgium
מתקן	עיר	מצב
Institut Jules Bordet	Anderlecht	פעיל, ללא גיוס
AZ Klina	Brasschaat	פעיל, ללא גיוס
Chirec Delta Hospital	Brussels	מגייס
Grand Hopital de Charleroi asbl (GHdC)	Gilly	פעיל, ללא גיוס
Jessa Ziekenhuis	Hasselt	מגייס
UZ Leuven	Leuven	מגייס
Clinique CHC MontLégia	Liège	מגייס
AZ Delta vzw	Roeselare	מגייס
AZ Vitaz	Sint-Niklaas	פעיל, ללא גיוס
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus	Wilrijk	מגייס

Brazil

Brazil
מתקן	עיר	מצב
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil	Brasília	מגייס
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130	Curitiba	מגייס
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, Paraná	Curitiba	פעיל, ללא גיוס
Oncosite	Ijuí	מגייס
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil	Itajaí	מגייס
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN	Natal	מגייס
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340	Porto Alegre	מגייס
Av. Ipiranga 6690	Porto Alegre	מגייס
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil	Porto Alegre	מגייס
Hospital Esperança SA	Recife	פעיל, ללא גיוס
Instituto Santa Joana Recife de Ensino e Pesquisa	Recife	פעיל, ללא גיוס
Instituto D'Or de Pesquisa e Ensino - RJ	Rio de Janiero	פעיל, ללא גיוס
Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil	Salvador	מגייס
AMO Clinic - Rio Vermelho	Salvador	פעיל, ללא גיוס
Instituto D'Or de Pesquisa e Ensino SP	São Paulo	פעיל, ללא גיוס
Hospital Sirio Libanês - SP	São Paulo	פעיל, ללא גיוס
Av. Brigadeiro Luís Antônio 733, loja 8	São Paulo	מגייס
Martiiano de Carvalho 965	São Paulo	מגייס
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center	São Paulo	מגייס
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200	Teresina	מגייס

France

France
מתקן	עיר	מצב
CHU Amiens Picardie	Amiens	מגייס
Pôle Santé Léonard De Vinci - ROC37	Chambray-lès-Tours	מגייס
Institut de Cancerologie de Bourgogne	Dijon	מגייס
Clinique Victor Hugo	Le Mans	מגייס
chu de Limoges	Limoges	מגייס
Institut de Cancérologie de l'Ouest (ICO) - St Herblain	Loire Atlantique	מגייס
Hôpital Privé Jean Mermoz	Lyon	מגייס
Centre D'Oncologie de Gentilly	Nancy	מגייס
L'Hôpital Privé du Confluent	Nantes	מגייס

322 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

9 בספטמבר 2026
אתר נוסף
16 sites added (372 total)
356372

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05633654