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
- Pumitamig (drug), Nab-paclitaxel/Paclitaxel (drug), Gemcitabine (drug), Carboplatin (drug)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- Pumitamig — drug: Solution for intravenous (IV) infusion · Nab-paclitaxel/Paclitaxel — drug: IV infusion · Gemcitabine — drug: IV infusion · Carboplatin — drug: IV infusion · Eribulin — drug: IV infusion · Matching placebo — 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
- 558
- Started
- 2025-10-30
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast neoplasms
- • Phase3 - 558 participants
- • This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast neoplasms
Where?
- • Brighton - Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
- • Bristol - University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
- • Cottingham - Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
- • Edinburgh - Edinburgh Cancer Centre-Western General Hospital
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
More detail
The study consists of a: 1. Screening period (up to 28 days); 2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \[whichever comes first\]); 3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first). Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors: * Prior treatment with cancer immunotherapy (yes versus no) * On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin) * Geography (East Asia versus the rest of the world \[ROW\]) * PD-L1 status (combined positive score \[CPS\] less than \[\<\] 1 versus 1 less than or equal to \[\<=\] CPS \<10).
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
What the study is looking for
- ✓Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting treatment that helps your immune system fight cancer plus...
- ✓Have at least one measurable lesion as the targeted lesion based on (standard scan measurements).
- ✓activity scale (ECOG) performance status of 0 or 1.
Who cannot take part
- ✗Have received any of the following therapies or drugs prior to the initiation of trial:
- ✗Have received prior systemic anticancer therapy for advanced disease.
- ✗Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.
- ✗Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.
- ✗Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
See the full criteria
Where Is This Study? (15 UK sites)
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton BN2 5BE, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
Bristol BS2 8ED, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Edinburgh Cancer Centre-Western General Hospital
Edinburgh EH4 2LF, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
St Bartholomew's Hospital - Barts Health NHS Trust
London EC1A 7BE, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW2 1PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Royal Free Hospital - Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
North Wales Cancer Treatment C - Glan Clwyd Hospital
Rhyl LL18 5UJ, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent ST4 6QG, United Kingdom
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay TQ2 7AA, United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton WV10 0QP, United Kingdom
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