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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 participants recherchés372 sites11 pays

Catégories

Oncologie81%Dermatologie19%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Triple Negative Breast Cancer

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement1 514 participants recherchés

Promoteur et collaborateurs

  • Gilead Sciences Promoteur
  • Alliance Foundation Trials, LLC. Collaborateurs
  • NSABP Foundation Inc Collaborateurs
  • GBG Forschungs GmbH Collaborateurs

Groupes et interventions

  • 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.

Interventions

  • Médicament Capecitabine

    Tablets administered orally

  • Médicament Pembrolizumab

    Administered intravenously

  • Médicament Sacituzumab govitecan-hziy (SG)

    Administered intravenously

Critères de jugement

  1. Critère de jugement 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.

    Délai Up to 60 months

  2. Critère de jugement secondaire

    Overall Survival (OS)

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

    Délai Up to 96 months

  3. Critère de jugement secondaire

    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.

    Délai Up to 60 months

  4. Critère de jugement secondaire

    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.

    Délai Up to 60 months

  5. Critère de jugement secondaire

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

    Délai First dose date up to 38 months plus 30 days

  6. Critère de jugement secondaire

    Percentage of Participants Experiencing Laboratory Abnormalities

    Délai First dose date up to 38 months plus 30 days

  7. Critère de jugement secondaire

    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.

    Délai Up to 60 months

Dates

Date de début12 décembre 2022 (réelle)
Achèvement principal1 juin 2027 (estimée)
Achèvement1 août 2031 (estimée)
Première publication1 décembre 2022 (réelle)
Dernière mise à jour9 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

278 sites sont en recrutement

Australia

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

Belgium

ÉtablissementVilleÉtat ou régionStatut
Institut Jules BordetAnderlechtActif, sans recrutement
AZ KlinaBrasschaatActif, sans recrutement
Chirec Delta HospitalBrusselsEn recrutement
Grand Hopital de Charleroi asbl (GHdC)GillyActif, sans recrutement
Jessa ZiekenhuisHasseltEn recrutement
UZ LeuvenLeuvenEn recrutement
Clinique CHC MontLégiaLiègeEn recrutement
AZ Delta vzwRoeselareEn recrutement
AZ VitazSint-NiklaasActif, sans recrutement
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS AugustinusWilrijkEn recrutement

Brazil

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

France

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

322 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 9 septembre 2026

    Site ajouté

    16 sites added (372 total)

    356372

Registre: ClinicalTrials.gov · NCT########

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