NCT07294430Not yet recruitingPhase 2
Pilot study evaluating antibody imaging to predict response to antibody-drug conjugate (ADC) therapy.
OASIS-ImmunoPET_Antibody-based PET imaging and treatment response in breast cancer treated with an antibody-drug conjugate according to current standard indications.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Sept 2026
Brief summary (registry, in English)
To describe the association between the combination of pre-treatment [89Zr]-trastuzumab and early FDG PET/CT with metabolic response to T-DXd after 3 cycles.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 1 Nov 2026
- Lead sponsor
- Unicancer
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07294430
- EU CT number
- 2025-524369-26-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already treated with Trastuzumab deruxtecan (T-DXd)
Other illness
- Hypersensitivity at the ImmunoPET radioligands injection
Other
- Male patients
- Patients who are claustrophobic or unable to remain still for 30 minutes
- Female participant who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days after the final administration of study treatment
- Person deprived of their liberty or under protective custody or guardianship.
Who the study is looking for
- Female patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent;
- Patients enrolled in the prospective cohort of the OASIS study (NCT07259226);
- Patient with locally advanced or metastatic breast cancer eligible to receive T-DXd as part of their standard care;
- At baseline imaging at least two “target” lesions fulfilling the following criteria: (1) anatomically transaxial diameter ≥ 1.5 cm and measurable per RECIST1.1. and (2) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma;
- Patients must be willing and able to comply with the protocol for the duration of the trial;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.