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
- Patritumab deruxtecan (biological), Paclitaxel (drug), Nab-paclitaxel (drug), Capecitabine (drug)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- Patritumab deruxtecan — biological: Administered via intravenous (IV) infusion · Paclitaxel — drug: Administered via IV infusion · Nab-paclitaxel — drug: Administered via IV infusion · Capecitabine — drug: Administered via oral tablets · Pegylated liposomal doxorubicin — drug: Administered via IV infusion · Trastuzumab deruxtecan — biological: Administered via IV infusion · Rescue Medication — drug: Participants receive rescue medications according to each approved drug's product label.
- 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
- 2025-07-21
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase3 - 1,000 participants
- • Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • London - University College London Hospital ( Site 2206)
- • London - St Bartholomew s Hospital ( Site 2200)
- • Leicester - Leicester Royal Infirmary ( Site 2205)
- • Manchester - The Christie NHS Foundation Trust ( Site 2208)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.
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
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET)...
- ✓Has cancer that can be measured on scans 1.1 as assessed by the local site investigator/radiology
- ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- ✓Has an activity scale performance status of 0 or 1 assessed within 7 days before randomization
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
- ✗Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
- ✗Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly...
- ✗Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ...
See the full criteria
Where Is This Study? (4 UK sites)
University College London Hospital ( Site 2206)
London NW1 2PG, United Kingdom
St Bartholomew s Hospital ( Site 2200)
London EC1A 7BE, United Kingdom
Leicester Royal Infirmary ( Site 2205)
Leicester LE1 5WW, United Kingdom
The Christie NHS Foundation Trust ( Site 2208)
Manchester M20 4BX, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
