Comparing Sacituzumab tirumotecan with Pembrolizumab for breast neoplasms
Official title: A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
- Phase 3
- 2 groups
- Sites in Surrey, Vancouver and 11 more cities
- Recruiting
Interventions (10)
- Biological therapy
Sacituzumab tirumotecan
IV infusion
- Biological therapy
Pembrolizumab
IV infusion
- Medication
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
- Medication
Carboplatin
IV infusion
- Medication
Paclitaxel
IV infusion
- Medication
Doxorubicin
IV infusion
- Medication
Epirubicin
IV infusion
- Medication
Cyclophosphamide
IV infusion
- Medication
Capecitabine
Oral tablet
- Medication
Olaparib
Oral tablet
Canadian Sites (15)
15 of 15 recruiting
- Recruiting
BC Cancer - Surrey ( Site 0217)
Surrey, British Columbia
- Recruiting
BC Cancer Vancouver ( Site 0218)
Vancouver, British Columbia
- Recruiting
NL Health Services ( Site 0232)
St. John's, Newfoundland and Labrador
- Recruiting
Royal Victoria Regional Health Centre ( Site 0233)
Barrie, Ontario
- Recruiting
Health Sciences North ( Site 0234)
Greater Sudbury, Ontario
- Recruiting
Lakeridge Health ( Site 0225)
Oshawa, Ontario
- Recruiting
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)
Ottawa, Ontario
- Recruiting
Sault Area Hospital ( Site 0226)
Sault Ste. Marie, Ontario
- Recruiting
Princess Margaret Cancer Centre ( Site 0208)
Toronto, Ontario
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0201)
Montreal, Quebec
- Recruiting
Jewish General Hospital ( Site 0200)
Montreal, Quebec
- Recruiting
McGill University Health Centre ( Site 0202)
Montreal, Quebec
- Recruiting
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)
Québec, Quebec
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0206)
Sherbrooke, Quebec
- Recruiting
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0204)
Trois-Rivières, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → include but are not limited to the following:
- +Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → based on radiological and/or clinical assessment:
- +cT1c, N1-N2
- +cT2, N0-N2
- +cT3, N0-N2
- +cT4a-d, N0-N2
- +Provides a core needle biopsy from the primary breast tumor at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → to the central laboratory.
- +Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
- +Demonstrates adequate organ function.
Exclusion
- −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → include but are not limited to the following:
- −Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
- −Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
- −Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
- −Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
- −Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
- −Received prior treatment with a topoisomerase I inhibitor-containing ADC.
- −Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- −Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- −Uncontrolled systemic disease.
- −History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →..
- −Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Capecitabine and Olaparib.
Registry label: A: sac-TMT
Group B, the comparison group, receives one or more of: Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Capecitabine and Olaparib.
Registry label: B: Chemotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,400 people.
The study is currently expected to finish around December 2034.
The main measurement is taken over: Up to approximately 30 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery — measured over Up to approximately 30 weeks.
Event-Free Survival (EFS) — measured over Up to approximately 92 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06966700 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Sacituzumab tirumotecanBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PembrolizumabBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Rescue MedicationDrug
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DoxorubicinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EpirubicinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CyclophosphamideDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CapecitabineDrug
Oral tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OlaparibDrug
Oral tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 30 weeks.
The study as a whole is currently expected to finish around 2034-12-29.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; St. John's, Newfoundland and Labrador, Canada; Barrie, Ontario, Canada; Greater Sudbury, Ontario, Canada; Oshawa, Ontario, Canada, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
Other Sites (3)
Fred Hutchinson Cancer Center ( Site 0069)
Seattle, Washington, United States
Cancer Care Northwest ( Site 0003)
Spokane, Washington, United States
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.