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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati372 centri11 paesi

Categorie

Oncologia81%Dermatologia19%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Triple Negative Breast Cancer

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento1514 partecipanti ricercati

Sponsor e collaboratori

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

Bracci e interventi

  • 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.

Interventi

  • Farmaco Capecitabine

    Tablets administered orally

  • Farmaco Pembrolizumab

    Administered intravenously

  • Farmaco Sacituzumab govitecan-hziy (SG)

    Administered intravenously

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale Up to 60 months

  2. Esito secondario

    Overall Survival (OS)

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

    Orizzonte temporale Up to 96 months

  3. Esito secondario

    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.

    Orizzonte temporale Up to 60 months

  4. Esito secondario

    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.

    Orizzonte temporale Up to 60 months

  5. Esito secondario

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

    Orizzonte temporale First dose date up to 38 months plus 30 days

  6. Esito secondario

    Percentage of Participants Experiencing Laboratory Abnormalities

    Orizzonte temporale First dose date up to 38 months plus 30 days

  7. Esito secondario

    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.

    Orizzonte temporale Up to 60 months

Date

Data di inizio12 dicembre 2022 (effettiva)
Conclusione primaria1 giugno 2027 (stimata)
Conclusione1 agosto 2031 (stimata)
Prima pubblicazione1 dicembre 2022 (effettiva)
Ultimo aggiornamento9 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

278 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Cancer Research SAAdelaideSouth AustraliaIn reclutamento
Bendigo HealthBendigoVictoriaIn reclutamento
Cairns HospitalCairnsQueenslandIn reclutamento
Macarthur Cancer Therapy Centre, Campbelltown HospitalCampbelltownNew South WalesIn reclutamento
Monash Medical CentreClaytonVictoriaIn reclutamento
Kinghorn Cancer CentreDarlinghurstNew South WalesIn reclutamento
Townsville University HospitalDouglassQueenslandIn reclutamento
Lake Macquarie Private HospitalGatesheadNew South WalesIn reclutamento
Fiona Stanley HospitalMurdochWestern AustraliaIn reclutamento
Port Macquarie Base HospitalPort MacquarieNew South WalesIn reclutamento
Princess Alexandra HospitalWoolloongabbaQueenslandIn reclutamento

Belgium

StrutturaCittàStato o regioneStato
Institut Jules BordetAnderlechtAttivo, non in reclutamento
AZ KlinaBrasschaatAttivo, non in reclutamento
Chirec Delta HospitalBrusselsIn reclutamento
Grand Hopital de Charleroi asbl (GHdC)GillyAttivo, non in reclutamento
Jessa ZiekenhuisHasseltIn reclutamento
UZ LeuvenLeuvenIn reclutamento
Clinique CHC MontLégiaLiègeIn reclutamento
AZ Delta vzwRoeselareIn reclutamento
AZ VitazSint-NiklaasAttivo, non in reclutamento
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS AugustinusWilrijkIn reclutamento

Brazil

StrutturaCittàStato o regioneStato
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, BrasilBrasíliaIn reclutamento
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130CuritibaIn reclutamento
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, ParanáCuritibaAttivo, non in reclutamento
OncositeIjuíIn reclutamento
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, BrasilItajaíIn reclutamento
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RNNatalIn reclutamento
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340Porto AlegreIn reclutamento
Av. Ipiranga 6690Porto AlegreIn reclutamento
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , BrasilPorto AlegreIn reclutamento
Hospital Esperança SARecifeAttivo, non in reclutamento
Instituto Santa Joana Recife de Ensino e PesquisaRecifeAttivo, non in reclutamento
Instituto D'Or de Pesquisa e Ensino - RJRio de JanieroAttivo, non in reclutamento
Av. Milton Santos, 123 - Ondina, Salvador - BA, , BrasilSalvadorIn reclutamento
AMO Clinic - Rio VermelhoSalvadorAttivo, non in reclutamento
Instituto D'Or de Pesquisa e Ensino SPSão PauloAttivo, non in reclutamento
Hospital Sirio Libanês - SPSão PauloAttivo, non in reclutamento
Av. Brigadeiro Luís Antônio 733, loja 8São PauloIn reclutamento
Martiiano de Carvalho 965São PauloIn reclutamento
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer CenterSão PauloIn reclutamento
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200TeresinaIn reclutamento

France

StrutturaCittàStato o regioneStato
CHU Amiens PicardieAmiensIn reclutamento
Pôle Santé Léonard De Vinci - ROC37Chambray-lès-ToursIn reclutamento
Institut de Cancerologie de BourgogneDijonIn reclutamento
Clinique Victor HugoLe MansIn reclutamento
chu de LimogesLimogesIn reclutamento
Institut de Cancérologie de l'Ouest (ICO) - St HerblainLoire AtlantiqueIn reclutamento
Hôpital Privé Jean MermozLyonIn reclutamento
Centre D'Oncologie de GentillyNancyIn reclutamento
L'Hôpital Privé du ConfluentNantesIn reclutamento

Nella scheda del registro sono indicati altri 322 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 9 settembre 2026

    Centro aggiunto

    16 sites added (372 total)

    356372

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

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