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Triple Negative Breast CancerCUPCAKENCT06225505

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

A study testing ctDNA monitoring and 68Ga-FAPI-46-PET-CT in people with Triple Negative Breast Cancer, run by Institut Curie at 13 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
ctDNA monitoring and 68Ga-FAPI-46-PET-CT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
13 sitesFrance
Study dates
5 Jan 2026to 3 Aug 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have signed a written informed consent before inclusion
  • Patients must be female ≥ 18 years old
  • Patients diagnosed with a non-metastatic TNBC (ER \& PR <10%, HER2- per ASCO/CAP guidelines). Patients must have been previously evaluated by a 18F-FDG PET-CT or a bone scintigraphy combined with a thorax, abdomen and pelvis CT scan with contrast
  • Patients who have undergone surgery with curative intent for their non-metastatic TNBC. Surgery must have been performed between 3 to 24 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 12 weeks. For patients receiving an experimental adjuvant treatment in a clinical trial, any intervention planned as part of this trial must be completed before inclusion.
  • High-risk primary tumor, defined as:
  • Lack of pathological complete response after neoadjuvant chemotherapy (RCB I, II or III; RCB I being capped to a maximum of 30% of included patients) OR, in the absence of neoadjuvant chemotherapy,
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  • Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR
  • Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
  • No sign of local or distant relapse, as per investigator assessment
  • Performance status < 2
  • Available FFPE tumor block with > 10% cellularity or 11 tumor sections with >10% cellularity
  • Patient able to comply with protocol requirements
  • Patients covered by a health insurance

Who cannot join

  • Any uncontrolled disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, interferes with the trial procedures
  • Male participants
  • Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
  • Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
  • Person deprived of liberty or under guardianship
  • History of another primary malignancy except for the following :
Show all 9Show fewer
  • Basal cell carcinoma or any in situ carcinoma treated with curative intent
  • Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years
  • For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Claire COYNE contact

0147111515

drci.promotion@curie.fr

13 sites in 1 country

France13 sites, 13 recruiting

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    Avignon, 84918

    Julien GRENIER

    Julien GRENIER

    Not yet recruiting

  • Institut Bergonié

    Bordeaux, 33000

    Monica ARNEDOS, MD

    Monica ARNEDOS, MD

    Not yet recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Marie-Ange MOURET-REYNIER

    Marie-Ange MOURET-REYNIER, MD

    Not yet recruiting

  • Centre Leon Bérard

    Lyon, 69008

    Olivier TREDAN, MD

    Olivier TREDAN

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Renaud SABATIER, MD

    Renaud SABATIER, MD

    Not yet recruiting

  • Institut du cancer de Montpellier

    Montpellier, 34298

    William JACOT, MD

    William JACOT, MD

    Not yet recruiting

  • CHU Nîmes

    Nîmes, 30900

    Frédéric FITENI, MD

    Frédéric FITENI, MD

    Not yet recruiting

  • Hôpital Saint-Louis

    Paris, 75010

    Louis TEXEIRA, MD

    Louis TEXEIRA, MD

    Not yet recruiting

  • Hôpital Tenon

    Paris, 75020

    Joseph GLIGOROV

    Joseph GLIGOROV

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Thibault DE LA MOTTE ROUGE, MD

    Thibault DE LA MOTTE ROUGE, MD

    Not yet recruiting

  • Institut Curie

    Saint-Cloud, 92340

    François-Clément BIDARD

    François-Clément BIDARD, MD

    Recruiting

  • ONCOPOLE Claudius Regaud

    Toulouse, 31059

    Florence DALENC, MD

    Florence DALENC

    Not yet recruiting

  • Institut de cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Vincent MASSARD, MD

    Vincent MASSARD, MD

    Not yet recruiting

Other trials in France

About this study

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

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.

Read the detailed description

The CUPCAKE trial will follow the Trials within Cohorts (TwiCs) approach. Non-metastatic TNBC patients at high risk of relapse will be included, after having signed a written informed consent, in a cohort allowing them to be followed by ctDNA monitoring every 4 months.

For each patient included, a ctDNA detection assay will be performed in blood samples every 4 months for a maximum of 24 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.

First line therapy will not be started until a metastatic relapse has been found by imagining: no treatment will be started in the sole basis of a positive ctDNA test.

If, at any timepoint, ctDNA is detected (molecular relapse), patients will be randomized in a 1:1 ratio.

  • In the experimental arm, patients and their treating physician will be made aware of the molecular relapse (positive ctDNA detection results). 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. If/when a clinical/radiological relapse is observed, the patient performance status will be registered (secondary objective) and systemic or local treatments will be decided by physicians. These treatments could be informed by the genetic landscape of the relapse, assessed by ctDNA.
  • In the control arm, patients and their treating physician will not be made aware of the molecular relapse and will continue the standard surveillance with repeated ctDNA test every 4 months (blinded) for a maximum of 24 months from enrolement in the study. At the time of the clinical/radiological diagnosis of relapse, similar procedures will be performed (18F-FDG PET-CT, 68Ga-FAPI-46-PET-CT, and tumor genetic landscape assessment by ctDNA analysis).
Being tested
ctDNA monitoring, 68Ga-FAPI-46-PET-CT
Keywords
Triple negative breast cancer, 68Ga-FAPI-46, ctDNA
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ctDNA monitoringDiagnostic test

    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.

  • 68Ga-FAPI-46-PET-CTDiagnostic test

    ). 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.

Study groups in NCT06225505
Study groupRoleWhat they receive
Experimental armExperimentalIn the experimental arm, patients and their treating physician will be made aware of the molecular relapse (positive ctDNA detection results) in study steps 1 (ctDNA monitoring). 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.
Receives: Diagnostic Test: ctDNA monitoring; Diagnostic Test: 68Ga-FAPI-46-PET-CT
Control armSham comparatorIn the control arm, patients and their treating physician will not be made aware of the molecular relapse and will continue the standard surveillance with repeated ctDNA test every 4 months (blinded). ). At the time of the clinical/radiological diagnosis of relapse, similar procedures will be performed (18F-FDG PET-CT, 68Ga-FAPI-46-PET-CT, and tumor genetic landscape assessment by ctDNA analysis).
Receives: Diagnostic Test: ctDNA monitoring; Diagnostic Test: 68Ga-FAPI-46-PET-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    OS rate for the main analysis (primary endpoint) is defined as the percentage of patients still alive 36 months after the randomization. If the patient is not present at the 36th month visit, survival data may be obtained by other means, such as telephone contact with the patient, his family, his current physician, or consulting local death registries.

    A non-comparative analysis will be conducted in the experimental arm, and the control arm will serve as reference.

    Measured: 36 months

Secondary outcomes (8)

  1. Number of metastatic sites at the time of the clinical/radiological relapse.

    The number of metastatic sites upon clinical/radiological relapse will be defined post-hoc by the Adjudication Committee as the number of organs or systems in which metastases are detected at the time of the clinical/radiological relapse, among the following propositions: lymph nodes, bones, liver, lungs, central nervous system/meninges, peritoneum, others.

    Measured: Clinical/radiological relapse up to 36 months

  2. Recurrence-free survival

    RFS [recurrence-free survival], defined as the time from randomization to clinical/radiological relapse or death; PFS [progression-free survival], defined as the time from randomization to the first progression or death occurring after clinical/radiological relapse; 1L-PFS [first line PFS], defined as the time from clinical/radiological relapse to first progression or death ; 2L-PFS [second line PFS], defined as the time from first to second progression or death; progression being defined per RECIST criteria.

    Measured: Clinical/radiological relapse up to 36 months

  3. Overall response rate

    Best ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST 1.1, until first progression or last tumor assessment in the absence of progression. ORR will be reported with its 95% confidence interval by arm.

    Measured: 12 months

  4. Overal Survival

    Overall Survival is defined as the time between randomization and death.

    Measured: Up to 36 months

  5. Performance Status Scale

    Proportion of patients presenting with an altered general condition (PS ≥2) at first evidence of clinical or radiological relapse.

    The population of interest consists in randomized patients.

    Measured: Clinical/radiological relapse up to 36 months

  6. EORTC Core Quality of Life questionnaire (EORTC-QLQ-C30) with the QLQ-BR42 module

    The EORTC-QLQ-C30 questionnaire with the QLQ-BR42 is used to report health-related QoL in all included patients. Summary statistics of the scores for all functional/symptom scales will be calculated at each assessment time point, according to the scoring procedure recommended by the EORTC.

    All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.

    Measured: Clinical/radiological relapse up to 36 months

  7. 5-level EQ-5D version (EQ-5D-5L)

    1. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. A completely healthy patient would have a score of 11111. This 5-digit number can be converted into a score using a special algorithm that is not publicly available. This point value is called the EQ-5D-5L Index and represents the patient's health status.

    Measured: Clinical/radiological relapse up to 24 months

  8. Proportion of patients receiving local treatment for oligometastatic disease

    Proportion of patients receiving local treatment for oligometastatic disease

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start5 Jan 2026
  3. Primary completion3 Aug 2031 (estimated)
  4. Study completion3 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept 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. 68Ga-FAPI-46 is the radiopharmaceutical product. There is no study treatment (standard of Care).
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225505
Sponsor's protocol ID
IC 2022-02
Acronym
CUPCAKE
Status last verified
Jul 2026
First submitted
12 Dec 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A study testing ctDNA monitoring and 68Ga-FAPI-46-PET-CT in people with Triple Negative Breast Cancer, run by Institut Curie at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne-Claire COYNE (0147111515, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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