Clinical trial NCT06611891: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
Official title: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer Metastatic
Keywords: Breast Cancer Metastatic
Somatostatin Receptor Expression
PET-SCAN
68Ga-DOTATOC
Nuclear Oncology
177-Lu-Oxodotreotide
DOTATOC
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 25 patients: 25 patients with breast cancer labeled on the primary lesion ER+HER2-
Primary purpose: DIAGNOSTIC

Brief summary: DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

Detailed description: In women, breast cancer is the 1st largest cancer and accounted for 31% of new cancer cases in women in 2017. With 11,913 deaths in 2015, breast cancer is the 1st largest cancer death in women (19%) and the 3rd largest cancer death (men and women included) after lung and colorectal cancer. At initial diagnosis at any stage, approximately 31% of patients have regional lymph node involvement and 5 to 10% present metastatic involvement from the outset. Progression to a metastatic form occurs in about 20% of cases. The risk of metastatic evolution is variable depending on the histological subtype and is a major prognostic event directly impacting overall survival. DOTATOC-68Ga PET scans allows in vivo evaluation of SST2 somatostatin receptor expression. Its use is widely validated in clinical practice for the assessment of extension of neuroendocrine tumors. It is also being used to evaluate the feasibility of SST2-targeted internal radiotherapy therapy with Lutathera (177Lu-Oxodotreotide) in patients with metastatic small intestine neuroendocrine tumours.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Patients with metastatic breast cancer who have completed at least one first line of systemic therapy for metastatic breast cancer
* Patient labeled on the primary lesion ER+HER2- (20)
* Presence of metastatic liver and bone lesions identifiable with 18F-FDG PET-Scan
* Presence of at least 10 identifiable secondary lesions in 18F-FDG PET-Scan
* No therapeutic change between 18F-FDG PET-Scan and 68Ga-DOTATOC PET-Scan.
* Performing the PET scan with 68Ga-DOTATOC within a maximum of 21 days after the 18F-FDG PET-Scan
* Person affiliated to or benefiting from social security
* Person who has given written informed consent

Exclusion Criteria:

* Patients followed or with history of other active neoplastic pathology (including neuroendocrine tumor)
* Known allergy to 68Ga-DOTATOC or its excipients
* Subject refusing to sign the consent to participate
* Minor subject
* Subject excluded from another study
* Persons referred to Articles L1121-5 to L1121-8 of the Public Health Code (CSP)
* Subject cannot be contacted in case of emergency

Primary outcomes:
measure: Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
timeFrame: Baseline (during the PET examination)
Secondary outcomes:
measure: Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.
timeFrame: Baseline (during the PET examination)
measure: Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET
timeFrame: Baseline (during the PET examination)
measure: Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score
timeFrame: Baseline (during the PET examination)
measure: Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.
timeFrame: Baseline (during the PET examination)
measure: Correlation between the metabolic activity of 18F-FDG PET lesions and the expression of SST2 receptors in 68Ga-DOTATOC PET per lesion and per patient.
timeFrame: Baseline (during the PET examination)
measure: Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
timeFrame: Baseline (during the PET examination)
measure: Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
timeFrame: Baseline (during the PET examination)
measure: Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
timeFrame: Baseline (during the PET examination)
measure: Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient
timeFrame: Baseline (during the PET examination)
measure: Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
timeFrame: Baseline (during the PET examination)
measure: Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
timeFrame: Baseline (during the PET examination)
measure: Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
timeFrame: Baseline (during the PET examination)
measure: Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion
timeFrame: Baseline (during the PET examination)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Loic DJAILEB
role: PRINCIPAL_INVESTIGATOR
References:
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