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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Phase 31,514 participants sought372 sites11 countries

Registered in 1 registry

ClinicalTrials.govNCT05633654Open this record at ClinicalTrials.govSynced 2 weeks ago

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Trial information is shown as published by the registry, in its original language.

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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.

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.

Summary

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.

Conditions

Triple Negative Breast Cancer

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	1,514 participants sought

Sponsor and collaborators

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

Arms and 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

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

Outcome measures

Primary outcome
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.
Time frame Up to 60 months
Secondary outcome
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Time frame Up to 96 months
Secondary outcome
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.
Time frame Up to 60 months
Secondary outcome
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.
Time frame Up to 60 months
Secondary outcome
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame First dose date up to 38 months plus 30 days
Secondary outcome
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame First dose date up to 38 months plus 30 days
Secondary outcome
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.
Time frame Up to 60 months

Dates

Dates
Start date	December 12, 2022 (actual)
Primary completion	June 1, 2027 (estimated)
Completion	August 1, 2031 (estimated)
First posted	December 1, 2022 (actual)
Last updated	September 9, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

278 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Cancer Research SA	Adelaide	South Australia	Recruiting
Bendigo Health	Bendigo	Victoria	Recruiting
Cairns Hospital	Cairns	Queensland	Recruiting
Macarthur Cancer Therapy Centre, Campbelltown Hospital	Campbelltown	New South Wales	Recruiting
Monash Medical Centre	Clayton	Victoria	Recruiting
Kinghorn Cancer Centre	Darlinghurst	New South Wales	Recruiting
Townsville University Hospital	Douglass	Queensland	Recruiting
Lake Macquarie Private Hospital	Gateshead	New South Wales	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
Port Macquarie Base Hospital	Port Macquarie	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting

Belgium

Belgium
Facility	City	Status
Institut Jules Bordet	Anderlecht	Active, not recruiting
AZ Klina	Brasschaat	Active, not recruiting
Chirec Delta Hospital	Brussels	Recruiting
Grand Hopital de Charleroi asbl (GHdC)	Gilly	Active, not recruiting
Jessa Ziekenhuis	Hasselt	Recruiting
UZ Leuven	Leuven	Recruiting
Clinique CHC MontLégia	Liège	Recruiting
AZ Delta vzw	Roeselare	Recruiting
AZ Vitaz	Sint-Niklaas	Active, not recruiting
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus	Wilrijk	Recruiting

Brazil

Brazil
Facility	City	Status
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil	Brasília	Recruiting
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130	Curitiba	Recruiting
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, Paraná	Curitiba	Active, not recruiting
Oncosite	Ijuí	Recruiting
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil	Itajaí	Recruiting
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN	Natal	Recruiting
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340	Porto Alegre	Recruiting
Av. Ipiranga 6690	Porto Alegre	Recruiting
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil	Porto Alegre	Recruiting
Hospital Esperança SA	Recife	Active, not recruiting
Instituto Santa Joana Recife de Ensino e Pesquisa	Recife	Active, not recruiting
Instituto D'Or de Pesquisa e Ensino - RJ	Rio de Janiero	Active, not recruiting
Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil	Salvador	Recruiting
AMO Clinic - Rio Vermelho	Salvador	Active, not recruiting
Instituto D'Or de Pesquisa e Ensino SP	São Paulo	Active, not recruiting
Hospital Sirio Libanês - SP	São Paulo	Active, not recruiting
Av. Brigadeiro Luís Antônio 733, loja 8	São Paulo	Recruiting
Martiiano de Carvalho 965	São Paulo	Recruiting
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center	São Paulo	Recruiting
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200	Teresina	Recruiting

France

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

322 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 9, 2026
Site added
16 sites added (372 total)
356372

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Belgium

Brazil

France

Study documents

Changes over time