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

ConditionLocally Advanced or Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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;

Disqualifiers

Patients already treated with Trastuzumab deruxtecan (T-DXd);

Hypersensitivity at the ImmunoPET radioligands injection;

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Immuno-PET

    Procedure/Surgery

    Realization of an advanced molecular imaging exam to visualize the T-DXd target (HER2) expression throughout the body, at baseline and at treatment discontinuation. This procedure relies on the administration to the patient of a radioactive tracer \[89Zr\]-anti-HER2. This experimental imaging is associated to standard FDG-PET scans for tumor assessment.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Locally advanced or metastatic breast cancer treated with Trastuzumab deruxtecan (T-DXd)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Metabolic objective response rate

Metabolic objective response rate (ORR) is defined as the proportion of patients who achieved a confirmed complete metabolic response (CR) or partial metabolic response (PR) assessed by investigators according to PERCIST 1.0 after 3 cycles of treatment initiation.

Time frame
From treatment initiation to disease progression, up to 3 cycles of treatment (each cycle is 21 to 28 days).

Secondary outcomes

1

Metabolic objective response rate (ORR) at 6 months

Metabolic objective response rate (ORR) is defined as the proportion of patients who achieved a confirmed complete metabolic response (CR) or partial metabolic response (PR) assessed by investigators according to PERCIST 1.0 after 6 months of treatment.

Time frame
From treatment initiation to disease progression, up to 6 months of treatment
2

Radiological objective response rate (ORR)

Radiological ORR is defined as the proportion of patients who achieved a confirmed complete radiological response (CR) or partial radiological response (PR) assessed by investigators according to RECIST 1.1 after 3 cycles and 6 months of treatment initiation.

Time frame
From treatment initiation to objective response, up to 6 months
3

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) is defined as the time from treatment initiation to the first documented radiological or metabolic progression of disease or death, whatever the cause. Patients still alive at the cut-off time without documented progression (including lost to follow-up) will be censored at the time of the latest evaluable efficacy assessment.

Time frame
From treatment initiation to disease progression or death, up to 3 years
4

Radiological progression-free survival (PFS)

Radiological PFS defined as time from treatment initiation to the first documented radiological or progression of disease or death, whatever the cause.

Time frame
From treatment initiation to disease progression or death, up to 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Jules Bordet Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: