Search / Trial NCT06225505

Early Detection of Triple Negative Breast Cancer Relapse

Launched by INSTITUT CURIE · Jan 16, 2024

Trial Information

Current as of December 30, 2024

Not yet recruiting

Keywords

Triple Negative Breast Cancer 68 Ga Fapi 46 Ct Dna

ClinConnect Summary

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 3 months.

For each patient included, a ctDNA detection assay will be performed in blood samples every 3 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 wil...

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.

Trial Officials

François-Clément BIDARD

Principal Investigator

Institut Curie

About Institut Curie

Institut Curie is a prestigious French research institute dedicated to the fight against cancer, renowned for its integration of cutting-edge research, innovative therapies, and comprehensive patient care. Established in 1909, it combines academic excellence with clinical expertise, facilitating groundbreaking studies and clinical trials aimed at advancing cancer treatment and improving patient outcomes. With a multidisciplinary approach, Institut Curie collaborates with leading scientists and healthcare professionals, fostering a dynamic environment for the development of novel therapeutic strategies and personalized medicine in oncology. Its commitment to research and patient-centered care positions Institut Curie as a pivotal player in the global cancer research community.

Locations

Clermont Ferrand, , France

Paris, , France

Marseille, , France

Rennes, , France

Paris, , France

Bordeaux, , France

Montpellier, , France

Lyon, , France

Vandœuvre Lès Nancy, , France

Nîmes, , France

Toulouse, , France

Avignon, , France

Saint Cloud, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0