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
- Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Rescue Medication (drug), Paclitaxel (drug)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- Sacituzumab tirumotecan — biological: IV Infusion · Pembrolizumab — biological: IV Infusion · Rescue Medication — drug: Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. · Paclitaxel — drug: IV Infusion · Nab-paclitaxel — drug: IV Infusion · Gemcitabine — drug: IV Infusion · Carboplatin — drug: IV Infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2025-03-16
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for triple negative breast neoplasms
- • Phase3 - 1,000 participants
- • Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with triple negative breast neoplasms
Where?
- • Truro - Royal Cornwall Hospital ( Site 4003)
- • London - St Bartholomew's Hospital ( Site 4001)
- • London - University College London Hospital ( Site 4007)
- • Nottingham - Nottingham University Hospital NHS Trust ( Site 4009)
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
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:
- ✓ completed all prior therapy for early-stage breast cancer with curative intent at least 6 months
- ✓ recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Has locally recurrent unresectable or that has spread TNBC that cannot be treated with curative intent
- ✓Has not received systemic treatment for locally recurrent unresectable or that has spread breast cancer
- ✓Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or...
- ✓Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Has breast cancer amenable to treatment with curative intent
- ✗Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
- ✗Has received prior treatment that goes through your whole body for treatment of locally recurrent unresectable or that has spread breast cancer
- ✗Has Grade ≥2 peripheral neuropathy
See the full criteria
Where Is This Study? (8 UK sites)
Royal Cornwall Hospital ( Site 4003)
Truro TR13LJ, United Kingdom
St Bartholomew's Hospital ( Site 4001)
London EC1A7BE, United Kingdom
University College London Hospital ( Site 4007)
London NW1 2PG, United Kingdom
Nottingham University Hospital NHS Trust ( Site 4009)
Nottingham NG51PB, United Kingdom
Musgrove Park Hospital ( Site 4005)
Taunton TA1 5DA, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 4017)
Birmingham B15 2TH, United Kingdom
Velindre Cancer Centre Hospital ( Site 4008)
Cardiff CF142TL, United Kingdom
St. James s University Hospital ( Site 4004)
Leeds LS9 7TF, United Kingdom
How to Get in Touch
Toll Free Number
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