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Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

NCT06225505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-01-22

No results posted yet for this study

Summary

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse.

The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.

Conditions

Interventions

DIAGNOSTIC_TEST

ctDNA monitoring

For each patient included, a ctDNA detection assay will be performed in blood samples every 4 months, while extra-plasma will be banked. ctDNA results will be available with a turnaround time of less than 3 weeks. When negative, ctDNA detection results will not be disclosed to patients nor clinicians.

DIAGNOSTIC_TEST

68Ga-FAPI-46-PET-CT

). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician.

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Personalis Inc.

    collaborator INDUSTRY

  • UNICANCER

    collaborator OTHER

  • Institut Curie

    lead OTHER

Principal Investigators

  • François-Clément BIDARD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2031-08-03
Completion
2031-08-03

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225505 on ClinicalTrials.gov