NCT06393374ClinicalTrials.gov

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 31.530 Teilnehmende gesucht311 Studienzentren31 Länder

Kategorien

Onkologie76%Dermatologie24%

In 1 Register registriert

ClinicalTrials.govNCT06393374Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vorgestern

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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 2024-05-01; recorded start 2024-06-24
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 661 other studies in this databaseCounted from the lead sponsor named in the record (Merck Sharp & Dohme LLC)
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: 305 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: 1,530 participants (target), run at 311 sites, across 31 countries.

How this score is built

Enrolment32/40
1,530 participants (target)
Site count25/25
305 sites
Country count15/15
31 countries
Planned duration10/10
Planned over about 164 months
Sponsor scale10/10
Merck Sharp & Dohme LLC has led 648 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

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Erkrankungen

Triple-Negative Breast Cancer

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC * Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery * Has non-pathologic complete response at surgery * Is able to continue on adjuvant pembrolizumab * Randomization must be conducted within 16 weeks from surgical resection * Completed adjuvant radiation therapy (if indicated) and recovered before randomization * Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception * For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available * Has Grade \>2 peripheral neuropathy * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC * Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks * Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active hepatitis B and hepatitis C virus infection * Has history of allogeneic tissue/solid organ transplant

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

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	1.530 Teilnehmende gesucht

Sponsor und Mitwirkende

Merck Sharp & Dohme LLC Sponsor

Studienarme und Interventionen

Pembrolizumab + sacituzumab tirumotecanEXPERIMENTAL
Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Treatment of Physician's ChoiceACTIVE_COMPARATOR
Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.

Interventionen

Arzneimittel Capecitabine
Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
Biologikum Pembrolizumab
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Biologikum Sacituzumab tirumotecan
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

Endpunkte

Primärer Endpunkt
Invasive Disease-Free Survival (iDFS)
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
Zeitrahmen Up to ~77 months
Sekundärer Endpunkt
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Zeitrahmen Up to ~101 months
Sekundärer Endpunkt
Distant recurrence-free survival (DRFS)
DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.
Zeitrahmen Up to ~101 months
Sekundärer Endpunkt
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Zeitrahmen Baseline and up to ~60 months
Sekundärer Endpunkt
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.
Zeitrahmen Baseline and up to ~60 months
Sekundärer Endpunkt
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.
Zeitrahmen Baseline and up to ~60 months
Sekundärer Endpunkt
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1 = "Not at All" to 4 = "Very Much"). Lower scores indicate a better level of fatigue.
Zeitrahmen Baseline and up to ~60 months
Sekundärer Endpunkt
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Zeitrahmen Up to ~42 weeks
Sekundärer Endpunkt
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Zeitrahmen Up to 24 weeks

Daten

Daten
Startdatum	24. Juni 2024 (tatsächlich)
Primärer Abschluss	16. Dezember 2030 (geschätzt)
Abschluss	14. Dezember 2037 (geschätzt)
Erstveröffentlichung	1. Mai 2024 (tatsächlich)
Zuletzt aktualisiert	17. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

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

Standorte

298 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Bundesland oder Region	Status
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)	Buenos Aires		Rekrutiert
Instituto de Oncología Angel H. Roffo ( Site 0503)	Buenos Aires	Buenos Aires F.D.	Rekrutiert
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)	Buenos Aires	Buenos Aires F.D.	Rekrutiert
Sanatorio Finochietto ( Site 0513)	Buenos Aires		Rekrutiert
Hospital Aleman-Oncology ( Site 0501)	Capital Federal	Buenos Aires	Rekrutiert
Hospital Británico de Buenos Aires-Oncology ( Site 0502)	Ciudad Autónoma de Buenos Aires	Buenos Aires	Rekrutiert
Sanatorio Parque ( Site 0512)	Rosario	Santa Fe Province	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)	Brisbane	Queensland	Rekrutiert
Frankston Hospital-Oncology and Haematology ( Site 2704)	Frankston	Victoria	Rekrutiert
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)	Macquarie University	New South Wales	Rekrutiert
Westmead Hospital ( Site 2700)	Westmead	New South Wales	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Bundesland oder Region	Status
Medizinische Universitaet Innsbruck ( Site 1200)	Innsbruck	Tyrol	Rekrutiert
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)	Linz	Upper Austria	Rekrutiert
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)	Salzburg		Rekrutiert
Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)	Vienna		Rekrutiert
Klinikum Wels-Grieskirchen ( Site 1205)	Wels	Upper Austria	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Bundesland oder Region	Status
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)	Brussels	Bruxelles-Capitale, Region de	Rekrutiert
AZ Maria Middelares-IKG ( Site 0903)	Ghent	Oost-Vlaanderen	Rekrutiert
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)	Namur		Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Bundesland oder Region	Status
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)	Fortaleza	Ceará	Rekrutiert
ANIMI - Unidade de Tratamento Oncologico ( Site 0616)	Lages	Santa Catarina	Rekrutiert
Hospital do Câncer Mãe de Deus ( Site 0604)	Porto Alegre	Rio Grande do Sul	Rekrutiert
Instituto de Oncologia Saint Gallen ( Site 0614)	Santa Cruz do Sul	Rio Grande do Sul	Rekrutiert
IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)	São Paulo		Rekrutiert
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)	Taubaté	São Paulo	Rekrutiert
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)	Teresina	Piauí	Rekrutiert
Hospital Santa Rita de Cassia ( Site 0617)	Vitória	Espírito Santo	Rekrutiert

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Cross Cancer Institute ( Site 0407)	Edmonton	Alberta	Rekrutiert
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)	Greenfield Park	Quebec	Rekrutiert
QEII Health Sciences Centre - Victoria General Site ( Site 0418)	Halifax	Nova Scotia	Rekrutiert
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0422)	Kingston	Ontario	Rekrutiert
The Moncton Hospital ( Site 0401)	Moncton	New Brunswick	Rekrutiert
Jewish General Hospital ( Site 0416)	Montreal	Quebec	Rekrutiert
Centre Hospitalier de l'Université de Montréal ( Site 0403)	Montreal	Quebec	Rekrutiert
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)	Montreal	Quebec	Rekrutiert
Southlake Health ( Site 0413)	Newmarket	Ontario	Abgeschlossen
The Ottawa Hospital - General Campus ( Site 0414)	Ottawa	Ontario	Rekrutiert
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)	Rimouski	Quebec	Rekrutiert
Princess Margaret Cancer Centre ( Site 0400)	Toronto	Ontario	Rekrutiert
North York General Hospital ( Site 0415)	Toronto	Ontario	Rekrutiert
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)	Trois-Rivières	Quebec	Rekrutiert
BC Cancer Vancouver ( Site 0404)	Vancouver	British Columbia	Rekrutiert
CancerCare Manitoba ( Site 0411)	Winnipeg	Manitoba	Rekrutiert

Colombia

Colombia
Einrichtung	Stadt	Bundesland oder Region	Status
Instituto Nacional De Cancerologia ( Site 3701)	Bogotá	Bogota D.C.	Rekrutiert
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)	Bogotá	Bogota D.C.	Rekrutiert
Clinica Somer ( Site 3704)	Rionegro	Antioquia	Rekrutiert
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)	Valledupar	Cesar Department	Rekrutiert

Czechia

Czechia
Einrichtung	Stadt	Bundesland oder Region	Status
Masarykuv onkologicky ustav ( Site 1005)	Brno	Brno-mesto	Rekrutiert
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)	Olomouc	Olomouc Region	Rekrutiert
Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)	Prague	Praha 4	Rekrutiert

261 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

17. September 2026
Studienzentrum hinzugefügt
1 site added (311 total)
310311
3. September 2026
Studienzentrum hinzugefügt
1 site added (310 total)
309310
28. August 2026
Studienzentrum hinzugefügt
1 site added (309 total)
308309
7. August 2026
Studienzentrum hinzugefügt
1 site added (308 total)
307308
3. August 2026
Studienzentrum hinzugefügt
1 site added (307 total)
306307
27. Juli 2026
Studienzentrum hinzugefügt
1 site added (306 total)
305306

https://xmedica.io/trials/ctgov/NCT06393374