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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

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En resumen

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…

Fase 31514 participantes buscados372 centros11 países

Categorías

Oncología81%Dermatología19%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Triple Negative Breast Cancer

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción1514 participantes buscados

Patrocinador y colaboradores

  • Gilead Sciences Patrocinador
  • Alliance Foundation Trials, LLC. Colaboradores
  • NSABP Foundation Inc Colaboradores
  • GBG Forschungs GmbH Colaboradores

Grupos e intervenciones

  • 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.

Intervenciones

  • Fármaco Capecitabine

    Tablets administered orally

  • Fármaco Pembrolizumab

    Administered intravenously

  • Fármaco Sacituzumab govitecan-hziy (SG)

    Administered intravenously

Variables de resultado

  1. Variable de resultado principal

    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.

    Plazo Up to 60 months

  2. Variable de resultado secundaria

    Overall Survival (OS)

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

    Plazo Up to 96 months

  3. Variable de resultado secundaria

    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.

    Plazo Up to 60 months

  4. Variable de resultado secundaria

    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.

    Plazo Up to 60 months

  5. Variable de resultado secundaria

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

    Plazo First dose date up to 38 months plus 30 days

  6. Variable de resultado secundaria

    Percentage of Participants Experiencing Laboratory Abnormalities

    Plazo First dose date up to 38 months plus 30 days

  7. Variable de resultado secundaria

    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.

    Plazo Up to 60 months

Fechas

Fecha de inicio12 de diciembre de 2022 (real)
Finalización principal1 de junio de 2027 (estimada)
Finalización1 de agosto de 2031 (estimada)
Primera publicación1 de diciembre de 2022 (real)
Última actualización9 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

278 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Cancer Research SAAdelaideSouth AustraliaEn reclutamiento
Bendigo HealthBendigoVictoriaEn reclutamiento
Cairns HospitalCairnsQueenslandEn reclutamiento
Macarthur Cancer Therapy Centre, Campbelltown HospitalCampbelltownNew South WalesEn reclutamiento
Monash Medical CentreClaytonVictoriaEn reclutamiento
Kinghorn Cancer CentreDarlinghurstNew South WalesEn reclutamiento
Townsville University HospitalDouglassQueenslandEn reclutamiento
Lake Macquarie Private HospitalGatesheadNew South WalesEn reclutamiento
Fiona Stanley HospitalMurdochWestern AustraliaEn reclutamiento
Port Macquarie Base HospitalPort MacquarieNew South WalesEn reclutamiento
Princess Alexandra HospitalWoolloongabbaQueenslandEn reclutamiento

Belgium

CentroCiudadEstado o regiónEstado
Institut Jules BordetAnderlechtActivo, sin reclutar
AZ KlinaBrasschaatActivo, sin reclutar
Chirec Delta HospitalBrusselsEn reclutamiento
Grand Hopital de Charleroi asbl (GHdC)GillyActivo, sin reclutar
Jessa ZiekenhuisHasseltEn reclutamiento
UZ LeuvenLeuvenEn reclutamiento
Clinique CHC MontLégiaLiègeEn reclutamiento
AZ Delta vzwRoeselareEn reclutamiento
AZ VitazSint-NiklaasActivo, sin reclutar
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS AugustinusWilrijkEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, BrasilBrasíliaEn reclutamiento
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130CuritibaEn reclutamiento
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, ParanáCuritibaActivo, sin reclutar
OncositeIjuíEn reclutamiento
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, BrasilItajaíEn reclutamiento
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RNNatalEn reclutamiento
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340Porto AlegreEn reclutamiento
Av. Ipiranga 6690Porto AlegreEn reclutamiento
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , BrasilPorto AlegreEn reclutamiento
Hospital Esperança SARecifeActivo, sin reclutar
Instituto Santa Joana Recife de Ensino e PesquisaRecifeActivo, sin reclutar
Instituto D'Or de Pesquisa e Ensino - RJRio de JanieroActivo, sin reclutar
Av. Milton Santos, 123 - Ondina, Salvador - BA, , BrasilSalvadorEn reclutamiento
AMO Clinic - Rio VermelhoSalvadorActivo, sin reclutar
Instituto D'Or de Pesquisa e Ensino SPSão PauloActivo, sin reclutar
Hospital Sirio Libanês - SPSão PauloActivo, sin reclutar
Av. Brigadeiro Luís Antônio 733, loja 8São PauloEn reclutamiento
Martiiano de Carvalho 965São PauloEn reclutamiento
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer CenterSão PauloEn reclutamiento
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200TeresinaEn reclutamiento

France

CentroCiudadEstado o regiónEstado
CHU Amiens PicardieAmiensEn reclutamiento
Pôle Santé Léonard De Vinci - ROC37Chambray-lès-ToursEn reclutamiento
Institut de Cancerologie de BourgogneDijonEn reclutamiento
Clinique Victor HugoLe MansEn reclutamiento
chu de LimogesLimogesEn reclutamiento
Institut de Cancérologie de l'Ouest (ICO) - St HerblainLoire AtlantiqueEn reclutamiento
Hôpital Privé Jean MermozLyonEn reclutamiento
Centre D'Oncologie de GentillyNancyEn reclutamiento
L'Hôpital Privé du ConfluentNantesEn reclutamiento

En el registro figuran 322 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 9 de septiembre de 2026

    Centro añadido

    16 sites added (372 total)

    356372

Registro: ClinicalTrials.gov · NCT########

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