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

NCT07294430 | Not Yet Recruiting Phase 2

• 2 other identifiers: UC-TRA-25212025-524369-26-00
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Locally Advanced or Metastatic Breast Cancer

Keywords

Advanced molecular imaging; ADC; Response

Outcome Measures

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.

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

Secondary Outcomes (7)

• Metabolic objective response rate (ORR) at 6 months

  From treatment initiation to disease progression, up to 6 months of treatment

• Radiological objective response rate (ORR)

  From treatment initiation to objective response, up to 6 months

• Progression-Free Survival (PFS)

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

• Radiological progression-free survival (PFS)

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

• Overall Survival (OS)

  From treatment initiation to death from any cause, up to 5 years

Study Arms (1)

Locally advanced or metastatic breast cancer treated with Trastuzumab deruxtecan (T-DXd)

EXPERIMENTAL

Experimental advanced molecular imaging (ImmunoPET) combining the high sensitivity and resolution of positron emission tomography (PET) with the specificity of ADC target specific monoclonal antibodies.

Procedure: Immuno-PET

Interventions

Immuno-PET PROCEDURE

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.

Locally advanced or metastatic breast cancer treated with Trastuzumab deruxtecan (T-DXd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients must be willing and able to comply with the protocol for the duration of the trial;

You may not qualify if:

• 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;
• Person deprived of their liberty or under protective custody or guardianship.

Sponsors & Collaborators

• UNICANCER: lead
• Jules Bordet Institute: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chromatin Immunoprecipitation Sequencing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques

Study Officials

• Barbara Pistilli, MD, PhD

  Gustave Roussy Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie Mauduit

CONTACT

0630481792; m-mauduit@unicancer.fr

Jérôme Lemonnier

CONTACT

j-lemonnier@unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 19, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share