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

Not Yet RecruitingPhase 2

Sponsor: UNICANCER

Conditions: Locally Advanced or Metastatic Breast Cancer

Interventions: Immuno-PET

OASIS-ImmunoPET is a monocentric pilot study evaluating antibody imaging to predict response to antibody-drug conjugate (ADC), an innovative cancer targeted therapy, and potentially replace tumor biopsy. It is addressed to patients with locally advanced or metastatic breast cancer who are eligible to receive the ADC Trastuzumab deruxtecan (T-DXd) according to local approval, and who are already enrolled in OASIS study (NCT pending).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.