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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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
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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…

Phase 31.514 Teilnehmende gesucht372 Studienzentren11 Länder

Kategorien

Onkologie81%Dermatologie19%

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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.

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

Zusammenfassung

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.

Erkrankungen

  • Triple Negative Breast Cancer

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungNONE (0)
Teilnahme1.514 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Gilead Sciences Sponsor
  • Alliance Foundation Trials, LLC. Mitwirkende
  • NSABP Foundation Inc Mitwirkende
  • GBG Forschungs GmbH Mitwirkende

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Capecitabine

    Tablets administered orally

  • Arzneimittel Pembrolizumab

    Administered intravenously

  • Arzneimittel Sacituzumab govitecan-hziy (SG)

    Administered intravenously

Endpunkte

  1. Primärer Endpunkt

    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.

    Zeitrahmen Up to 60 months

  2. Sekundärer Endpunkt

    Overall Survival (OS)

    OS is defined as the time from the date of randomization until death due to any cause.

    Zeitrahmen Up to 96 months

  3. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 60 months

  4. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 60 months

  5. Sekundärer Endpunkt

    Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Zeitrahmen First dose date up to 38 months plus 30 days

  6. Sekundärer Endpunkt

    Percentage of Participants Experiencing Laboratory Abnormalities

    Zeitrahmen First dose date up to 38 months plus 30 days

  7. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 60 months

Daten

Startdatum12. Dezember 2022 (tatsächlich)
Primärer Abschluss1. Juni 2027 (geschätzt)
Abschluss1. August 2031 (geschätzt)
Erstveröffentlichung1. Dezember 2022 (tatsächlich)
Zuletzt aktualisiert9. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

278 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Cancer Research SAAdelaideSouth AustraliaRekrutiert
Bendigo HealthBendigoVictoriaRekrutiert
Cairns HospitalCairnsQueenslandRekrutiert
Macarthur Cancer Therapy Centre, Campbelltown HospitalCampbelltownNew South WalesRekrutiert
Monash Medical CentreClaytonVictoriaRekrutiert
Kinghorn Cancer CentreDarlinghurstNew South WalesRekrutiert
Townsville University HospitalDouglassQueenslandRekrutiert
Lake Macquarie Private HospitalGatesheadNew South WalesRekrutiert
Fiona Stanley HospitalMurdochWestern AustraliaRekrutiert
Port Macquarie Base HospitalPort MacquarieNew South WalesRekrutiert
Princess Alexandra HospitalWoolloongabbaQueenslandRekrutiert

Belgium

EinrichtungStadtBundesland oder RegionStatus
Institut Jules BordetAnderlechtAktiv, rekrutiert nicht
AZ KlinaBrasschaatAktiv, rekrutiert nicht
Chirec Delta HospitalBrusselsRekrutiert
Grand Hopital de Charleroi asbl (GHdC)GillyAktiv, rekrutiert nicht
Jessa ZiekenhuisHasseltRekrutiert
UZ LeuvenLeuvenRekrutiert
Clinique CHC MontLégiaLiègeRekrutiert
AZ Delta vzwRoeselareRekrutiert
AZ VitazSint-NiklaasAktiv, rekrutiert nicht
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS AugustinusWilrijkRekrutiert

Brazil

EinrichtungStadtBundesland oder RegionStatus
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, BrasilBrasíliaRekrutiert
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130CuritibaRekrutiert
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, ParanáCuritibaAktiv, rekrutiert nicht
OncositeIjuíRekrutiert
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, BrasilItajaíRekrutiert
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RNNatalRekrutiert
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340Porto AlegreRekrutiert
Av. Ipiranga 6690Porto AlegreRekrutiert
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , BrasilPorto AlegreRekrutiert
Hospital Esperança SARecifeAktiv, rekrutiert nicht
Instituto Santa Joana Recife de Ensino e PesquisaRecifeAktiv, rekrutiert nicht
Instituto D'Or de Pesquisa e Ensino - RJRio de JanieroAktiv, rekrutiert nicht
Av. Milton Santos, 123 - Ondina, Salvador - BA, , BrasilSalvadorRekrutiert
AMO Clinic - Rio VermelhoSalvadorAktiv, rekrutiert nicht
Instituto D'Or de Pesquisa e Ensino SPSão PauloAktiv, rekrutiert nicht
Hospital Sirio Libanês - SPSão PauloAktiv, rekrutiert nicht
Av. Brigadeiro Luís Antônio 733, loja 8São PauloRekrutiert
Martiiano de Carvalho 965São PauloRekrutiert
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer CenterSão PauloRekrutiert
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200TeresinaRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
CHU Amiens PicardieAmiensRekrutiert
Pôle Santé Léonard De Vinci - ROC37Chambray-lès-ToursRekrutiert
Institut de Cancerologie de BourgogneDijonRekrutiert
Clinique Victor HugoLe MansRekrutiert
chu de LimogesLimogesRekrutiert
Institut de Cancérologie de l'Ouest (ICO) - St HerblainLoire AtlantiqueRekrutiert
Hôpital Privé Jean MermozLyonRekrutiert
Centre D'Oncologie de GentillyNancyRekrutiert
L'Hôpital Privé du ConfluentNantesRekrutiert

322 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 9. September 2026

    Studienzentrum hinzugefügt

    16 sites added (372 total)

    356372

Register: ClinicalTrials.gov · NCT########

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