Monitoring for Triple Negative Breast Cancer Relapse
Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
Recruiting
N/AInterventional Study
Triple Negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Diagnostic
Participants needed
450 (estimated)
Sponsor
Institut Curie · Other
Who this trial is looking for
This trial is looking for women who have been treated for early-stage triple negative breast cancer. Participants will have their blood tested for cancer markers and undergo imaging to check for any signs of cancer returning.
Are You a Good Fit for This Trial?
You may be able to join if
I am female and at least 18 years old
I have been diagnosed with non-metastatic triple negative breast cancer
I have had surgery to treat my breast cancer in the last 3 to 24 months
I am receiving adjuvant therapy and it has been at least 12 weeks since I started
I have a high-risk tumor as defined by the study criteria
I have no signs of cancer returning according to my doctor
I have a tumor sample available for testing
I have signed a consent form to participate
You may not be able to join if
I am male
I have an uncontrolled medical condition that might affect the trial
I have a mental health condition that affects my ability to give consent
I find it difficult to participate due to personal reasons
I am currently imprisoned or under guardianship
I have had another type of cancer in the past five years, except for certain non-invasive cancers
I have metastatic cancer detected before the study assessments
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 t…
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 Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients must have signed a written informed consent before inclusion
2. Patients must be female ≥ 18 years old
3. 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 o…
Inclusion Criteria:
1. Patients must have signed a written informed consent before inclusion
2. Patients must be female ≥ 18 years old
3. 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
4. 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.
5. High-risk primary tumor, defined as:
1. 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,
2. Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR
3. Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
6. No sign of local or distant relapse, as per investigator assessment
7. Performance status \< 2
8. Available FFPE tumor block with \> 10% cellularity or 11 tumor sections with \>10% cellularity
9. Patient able to comply with protocol requirements
10. Patients covered by a health insurance
Exclusion Criteria:
1. 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
2. Male participants
3. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
4. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
5. Person deprived of liberty or under guardianship
6. History of another primary malignancy except for the following :
1. Basal cell carcinoma or any in situ carcinoma treated with curative intent
2. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years
7. For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.
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