Trial Title:
Early Detection of Triple Negative Breast Cancer Relapse
NCT ID:
NCT06225505
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
FAPI-46
Conditions: Keywords:
Triple negative breast cancer
68Ga-FAPI-46
ctDNA
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial,
using the Trials within Cohorts concept 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.
68Ga-FAPI-46 is the radiopharmaceutical product. There is no study treatment (standard of
Care).
Primary purpose:
Diagnostic
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
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).
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ctDNA monitoring
Description:
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.
Arm group label:
Control arm
Arm group label:
Experimental arm
Intervention type:
Diagnostic Test
Intervention name:
68Ga-FAPI-46-PET-CT
Description:
). 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.
Arm group label:
Control arm
Arm group label:
Experimental arm
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 ~3 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.
Detailed description:
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 will not be started until a metastatic relapse has been found by
imagining: no treatment will be started in the sole basis of a positive ctDNA test.
If, at any timepoint, ctDNA is detected (molecular relapse), patients will be randomized
in a 1:1 ratio.
- In the experimental arm, patients and their treating physician will be made aware of
the molecular relapse (positive ctDNA detection results). 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. If/when a clinical/radiological relapse is
observed, the patient performance status will be registered (secondary objective)
and systemic or local treatments will be decided by physicians. These treatments
could be informed by the genetic landscape of the relapse, assessed by ctDNA.
- In 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 3 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).
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sainte-Catherine Institut du Caner Avignon-Provence
Address:
City:
Avignon
Zip:
84918
Country:
France
Contact:
Last name:
Julien GRENIER
Investigator:
Last name:
Julien GRENIER
Email:
Principal Investigator
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Contact:
Last name:
Monica ARNEDOS, MD
Investigator:
Last name:
Monica ARNEDOS, MD
Email:
Principal Investigator
Facility:
Name:
Centre Jean Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Contact:
Last name:
Marie-Ange MOURET-REYNIER
Investigator:
Last name:
Marie-Ange MOURET-REYNIER, MD
Email:
Principal Investigator
Facility:
Name:
Centre Leon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Contact:
Last name:
Renaud SABATIER, MD
Investigator:
Last name:
Renaud SABATIER, MD
Email:
Principal Investigator
Facility:
Name:
Institut du cancer de Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Contact:
Last name:
William JACOT, MD
Investigator:
Last name:
William JACOT, MD
Email:
Principal Investigator
Facility:
Name:
CHU Nîmes
Address:
City:
Nîmes
Zip:
30900
Country:
France
Contact:
Last name:
Frédéric FITENI, MD
Investigator:
Last name:
Frédéric FITENI, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Contact:
Last name:
Louis TEXEIRA, MD
Investigator:
Last name:
Louis TEXEIRA, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Contact:
Last name:
Joseph GLIGOROV
Investigator:
Last name:
Joseph GLIGOROV
Email:
Principal Investigator
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Contact:
Last name:
Thibault DE LA MOTTE ROUGE, MD
Investigator:
Last name:
Thibault DE LA MOTTE ROUGE, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92340
Country:
France
Contact:
Last name:
François-Clément BIDARD
Investigator:
Last name:
François-Clément BIDARD, MD
Email:
Principal Investigator
Facility:
Name:
ONCOPOLE Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Contact:
Last name:
Florence DALENC, MD
Investigator:
Last name:
Florence DALENC
Email:
Principal Investigator
Facility:
Name:
Institut de cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Contact:
Last name:
Vincent MASSARD, MD
Investigator:
Last name:
Vincent MASSARD, MD
Email:
Principal Investigator
Start date:
June 30, 2024
Completion date:
December 15, 2028
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Collaborator:
Agency:
National Research Agency, France
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06225505
