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 (drug), Pembrolizumab (biological), Paclitaxel (drug), Nab-paclitaxel (drug)
- How long the study runs
- Study runs about 84 months (dates as stated)
- About the drug or intervention
- Sacituzumab tirumotecan — drug: IV infusion · Pembrolizumab — biological: IV infusion · Paclitaxel — drug: IV infusion · Nab-paclitaxel — drug: IV infusion · Capecitabine — drug: oral tablet · Liposomal doxorubicin — 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
- 1,200
- Started
- 2024-04-14
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase3 - 1,200 participants
- • The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • Londonderry - North West Cancer Centre ( Site 1944)
- • Truro - The Royal Cornwall Hospital ( Site 1943)
- • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
- • London - University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
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:
- ✓ well controlled HIV on antiretroviral therapy
What the study is looking for
- ✓Has unresectable that has grown locally or that has spread centrally-confirmed hormone receptor positive (HR+)/human epidermal...
- ✓Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally...
- ✓Is a drug treatment candidate
- ✓Has an activity scale (ECOG) performance status of 0 to 1 assessed within 7 days before...
- ✓Has healthy organ
Who cannot take part
- ✗Has breast cancer amenable to treatment with curative intent
- ✗Has experienced an early recurrence (\<6 months after completing after surgery/before surgery drug treatment) and therefore is...
- ✗Has causing symptoms advanced/that has spread visceral spread at risk of rapidly evolving into life-threatening complications
- ✗Has received prior drug treatment for unresectable that has grown locally or that has spread breast cancer
- ✗Active autoimmune disease that has required systemic treatment in the past 2 years
See the full criteria
Where Is This Study? (6 UK sites)
North West Cancer Centre ( Site 1944)
Londonderry BT47 6SB, United Kingdom
The Royal Cornwall Hospital ( Site 1943)
Truro TR1 3LJ, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
London EC1A 7BE, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
London NW1 2PG, United Kingdom
Blackpool Victoria Hospital ( Site 1941)
Blackpool FY3 8NR, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
Toll Free Number
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