At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab (biological), Sacituzumab tirumotecan (biological), Capecitabine (drug)
- How long the study runs
- Study runs about 162 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — biological: Pembrolizumab 400 mg intravenous (IV) infusion q6w · Sacituzumab tirumotecan — biological: Sacituzumab tirumotecan 4 mg/kg IV infusion q2w · Capecitabine — drug: Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,530
- Started
- 2024-06-24
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for triple-negative breast cancer
- • Phase3 - 1,530 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with triple-negative breast cancer
Where?
- • Bristol - University Hospitals Bristol NHS Foundation Trust ( Site 2601)
- • Hills Road - Addenbrooke's Hospital ( Site 2609)
- • Truro - The Royal Cornwall Hospital ( Site 2603)
- • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ recovered to ≤Grade 1 or baseline (except alopecia)
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of...
- ✓Has no evidence of locoregional or distant relapse, as assessed by the treating physician
- ✓Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and...
- ✓Has non-disease complete response at surgery
- ✓Is able to continue on after surgery pembrolizumab
Who cannot take part
- ✗Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for...
- ✗Has Grade \>2 peripheral neuropathy
- ✗History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal...
- ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory...
- ✗Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or...
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals Bristol NHS Foundation Trust ( Site 2601)
Bristol BS2 8ED, United Kingdom
Addenbrooke's Hospital ( Site 2609)
Hills Road CB2 0QQ, United Kingdom
The Royal Cornwall Hospital ( Site 2603)
Truro TR1 3LJ, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
London EC1A 7BE, United Kingdom
University College London Hospital ( Site 2604)
London NW1 2PG, United Kingdom
Western General Hospital ( Site 2607)
Edinburgh EH4 2XU, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 2608)
Leeds LS9 7TF, United Kingdom
How to Get in Touch
Toll Free Number
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