Early Detection of Triple Negative Breast Cancer Relapse

Launched by INSTITUT CURIE · Jan 16, 2024

Keywords

ClinConnect Summary

The CUPCAKE clinical trial is designed to explore a new way to monitor women who have been treated for triple negative breast cancer (TNBC) and are at high risk for the cancer returning. The study will look at using blood tests to detect tiny pieces of cancer DNA (ctDNA) along with special imaging scans to see if cancer is coming back in patients who have completed their initial treatment. The trial has two steps: first, participants will have blood tests every three months to check for ctDNA. If ctDNA is found, they will be randomly assigned to one of two groups. One group will continue monitoring without immediate action, while the other group will receive additional scans to investigate further.

To be eligible for this trial, participants must be women aged 18 or older who have been diagnosed with non-metastatic TNBC and have undergone surgery to treat their cancer within the last 1 to 18 months. They should also be at high risk of relapse based on specific criteria. Participants can expect regular blood tests and, if ctDNA is detected, possible additional imaging tests. It's important to note that the trial is not currently recruiting, so it won't start enrolling participants just yet.

Gender

FEMALE

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 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 1 to 18 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 4 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.