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Early detection of triple negative breast cancer relapse (CUPCAKE)
EU CTIS ID: 2022-501562-22-01
What this study is testing
To evaluate the efficacy of ctDNA-based surveillance strategy, in terms of risk of early death
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have signed a written informed consent before inclusion
- Patients covered by a health insurance
- 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: a.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, b.Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR c. Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
You likely can't join 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 : a. Basal cell carcinoma or any in situ carcinoma treated with curative intent b. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years 6.7. For step #2 (randomization after ctDNA detection): clinical/radiological
See the full eligibility criteria
Who can join
- Patients must have signed a written informed consent before inclusion
- Patients covered by a health insurance
- 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: a.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, b.Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR c. 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
What rules you out
- 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 : a. Basal cell carcinoma or any in situ carcinoma treated with curative intent b. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years 6.7. For step #2 (randomization after ctDNA detection): clinical/radiological
- For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.