Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate.

Official record

Identifier

NCT07294430

Recruiting locations

Locations are not included in the offline baseline for this record. Open the official record to see the current site list.

Interventions studied

Immuno-PET

Lead sponsor

UNICANCER

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Not yet recruiting

First posted

Dec 19, 2025

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. 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;
2. Patients enrolled in the prospective cohort of the OASIS study;
3. Patient with locally advanced or metastatic breast cancer eligible to receive T-DXd as part of their standard care;
4. 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;
5. Patients must be willing and able to comply with the protocol for the duration of the trial;

Exclusion Criteria:

1. Patients already treated with Trastuzumab deruxtecan (T-DXd);
2. Hypersensitivity at the ImmunoPET radioligands injection;
3. Patients who are claustrophobic or unable to remain still for 30 minutes;
4. 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;
5. Person deprived of their liberty or under protective custody or guardianship.