RecruitingNot ApplicableNCT06225505

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial


Sponsor

Institut Curie

Enrollment

450 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a blood-based test (circulating tumor DNA, or ctDNA) to detect very early signs of triple-negative breast cancer (TNBC) returning, so that treatment can be started before a full relapse becomes visible on imaging. **You may be eligible if...** - You are a woman 18 years old or older - You have been diagnosed with non-metastatic triple-negative breast cancer - You had surgery to remove the cancer between 3 and 9 months before joining the study - You are considered high-risk (cancer did not completely disappear with pre-surgery chemotherapy, or was stage IIB or higher) - You have started any planned additional (adjuvant) treatment at least 12 weeks ago - There are no current signs of cancer returning **You may NOT be eligible if...** - You are male - Your cancer has already spread to other organs - You have had another cancer in the past 5 years (except certain early-stage or skin cancers) - You have a condition that would prevent you from following study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTctDNA 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_TEST68Ga-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.


Locations(13)

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, France

Institut Bergonié

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Leon Bérard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Institut du cancer de Montpellier

Montpellier, France

CHU Nîmes

Nîmes, France

Hôpital Saint-Louis

Paris, France

Hôpital Tenon

Paris, France

Centre Eugène Marquis

Rennes, France

Institut Curie

Saint-Cloud, France

ONCOPOLE Claudius Regaud

Toulouse, France

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

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NCT06225505


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