Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
CUPCAKE
1 other identifier
interventional
450
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 3, 2031
January 22, 2026
January 1, 2026
5.6 years
December 12, 2023
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
36 months
Secondary Outcomes (8)
Number of metastatic sites at the time of the clinical/radiological relapse.
Clinical/radiological relapse up to 36 months
Recurrence-free survival
Clinical/radiological relapse up to 36 months
Overall response rate
12 months
Overal Survival
Up to 36 months
Performance Status Scale
Clinical/radiological relapse up to 36 months
- +3 more secondary outcomes
Study Arms (2)
Experimental arm
EXPERIMENTALIn 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.
Control arm
SHAM 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).
Interventions
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.
). 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.
Eligibility Criteria
You may qualify if:
- 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
- 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,
- 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
You may not qualify if:
- 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 :
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
- National Research Agency, Francecollaborator
- Roche Pharma AGcollaborator
- Personalis Inc.collaborator
- UNICANCERcollaborator
Study Sites (13)
Sainte-Catherine Institut du Caner Avignon-Provence
Avignon, 84918, France
Institut Bergonié
Bordeaux, 33000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Leon Bérard
Lyon, 69008, France
Institut Paoli-Calmettes
Marseille, 13009, France
Institut du cancer de Montpellier
Montpellier, 34298, France
CHU Nîmes
Nîmes, 30900, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Tenon
Paris, 75020, France
Centre Eugène Marquis
Rennes, 35000, France
Institut Curie
Saint-Cloud, 92340, France
ONCOPOLE Claudius Regaud
Toulouse, 31059, France
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François-Clément BIDARD
Institut Curie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Upon detection of ctDNA during Step1, patients will be centrally assigned to the control or the experimental arm (1:1) using the eCRF. Randomization will be stratified by RCB score (I/II vs. III/NA because no neoadjuvant chemotherapy) and by time to molecular relapse (\< 12 months vs. ≥ 12 months between surgery and molecular relapse).
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2023
First Posted
January 26, 2024
Study Start
January 5, 2026
Primary Completion (Estimated)
August 3, 2031
Study Completion (Estimated)
August 3, 2031
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
- Access Criteria
- Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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.