Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Women aged 18 years or older (2) Subjects with newly diagnosed (early or advanced) breast cancer (3) Eastern Cooperative Oncology Group (ECOG) performance status =2 (4) Adequate bone marrow, liver and renal function, with: • Calculated glomerular filtration rate (GFR): =45 mL/min • Albumin: >30 g/L • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): =5 times upper limit of normal (ULN) • Bilirubin: =3xULN (3×1.1 mg/dL) • Leukocytes: =3x109/L, and neutrophils: =1x109/L • Erythrocytes: =3.5x1012/L • Platelets: =90x109/L (5) Signed written informed consent prior to any study-related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: (1) Subject with resected primary tumour (2) Subjects with confirmed ductal carcinoma in situ (3) Men with breast cancer (4) Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis (5) Subjects who have received any therapy for breast cancer (6) Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide (7) Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration (8) Any condition that precludes the proper performance of PET and/or CT scan: • Subjects who are not able to tolerate the CT contrast agent • Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis • Subjects unable to raise arms for prolonged imaging purposes • Subjects unable to lie still for the entire imaging time • Subjects weighing greater than 110 kg (243 lb) (9) Known hypersensitivity to radiolabelled NODAGA (1,4,7-triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide JR11 or to any of the excipients of 68Ga-OPS202 (10) History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids (11) Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C (12) Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration (13) Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga OPS202 administration (14) Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude (15) Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus, and/or subjects treated with curative intent and free from disease for more than 5 years)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the percentage of women with newly diagnosed breast cancer who have sstr2 positive lesions that are identified using 68Ga-OPS202 - To define the optimal PET imaging time of 68Ga-OPS202 at 0.5, 1.0 and 2 hours post injection, based on detected lesions in adult women with sstr2 positive newly diagnosed early or advanced breast cancer ; Secondary Objective: Secondary objectives: - To further define the optimal uptake time of 68Ga-OPS202 based on quantitative SUVmax and other quality parameters - To describe the safety and tolerability of 68Ga-OPS202 in women with newly diagnosed (early or advanced) sstr2 positive breast cancer Exploratory objectives: - To provide preliminary estimates of the sensitivity of 68Ga-OPS202 PET/CT scan imaging, as well as SUV ratio (SUVmax lesion/SUVmean reference tissue) and signal-to- noise ratios (SNR) - To assess the correlation in terms of number of avid lesions between 18F-fluorodeoxyglucose (18F-FDG)-PET and 68Ga-OPS202 - To assess the correlation between 68Ga-OPS202 tumour uptake with results from immunohistochemistry staining of sstr2. ; Primary end point(s): Efficacy: - Percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion. (Avid is defined by the blinded readers at one of the acquisition timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68Ga-OPS202 and 1.5-fold or greater uptake than the non-tumoural liver and lung parenchyma). - Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours), and reader interpretation of optimal image(s) in the primary breast lesions. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - 68Ga-OPS202 PET/CT at Visit 2: o PET at 0.5, 1 and 2 hours after 68Ga-OPS202 administration, o ceCT after either of the 2 PET (18F-FDG-PET or 68Ga OPS202 post 2-hour acquisition). Low-dose CT will be acquired for the other PET when the ceCT is not obtained. - Tumor biopsy will be performed (if not already done) at Visit 1 (Day -14 to Day -1). - 18F-FDG-PET scan: any time during the study period - Haematology: Visits 1, 2 & 3 - Blood chemistry: Visits 1, 2 & 3 - Urinalysis: Visits 1, 2 & 3 - ECG: Visits 1 & 3 - Physical examination: Visits 1, 2 & 3 - Vital signs: Visits 1, 2 & 3 (0.5, 1, 2 and 4 hours post injection) - Adverse events: all through study participation - Concomitant therapies: From 3 months prior to injection, Visits 1, 2 & 3 ; Secondary end point(s): I - Secondary endpoints Key secondary: • Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours), and reader interpretation of optimal image(s) in nodular and metastatic lesions. Significant uptake of 68Ga-OPS202 for the evaluation of a lesion is an avid lesion defined by the blinded readers at one of the acquisition timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68Ga OPS202 and 1.5-fold or greater uptake than in the non-tumoural liver and lung parenchyma. • The SUVmean and SUVmax in the primary lesion between each of the three timepoints, measured in the most avid lesions (using the 68Ga-OPS202 scans). This is assessed by the tumour-to-background ratio in the primary tumour and each of the major anatomic sites (liver, lymph nodes, bone, lungs and brain); the backgroun | — |
Countries
Austria, Belgium
Contacts
Public ContactClinical Trial Information
Ipsen Pharma
Outcome results
None listed