Intervention: Satoreotide trizoxetan
Trial phase: Phase 2
SMILES: [H][C@]1(Cc2ccc(NC(N)=O)cc2)NC(=O)[C@H](Cc2ccc(NC(=O)[C@@H]3CC(=O)NC(=O)N3)cc2)NC(=O)[C@H](NC(=O)[C@H](Cc2ccc(Cl)cc2)NC(=O)CCC(C(=O)O)N2CCN(CC(=O)O)CCN(CC(=O)O)CC2)CSSC[C@@H](C(=O)N[C@H](Cc2ccc(O)cc2)C(N)=O)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](CCCCN)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: A single dose of 68Ga-satoreotide trizoxetan was administered as a slow iv bolus injected over 1 minute on Day 1.

The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 MBq.
Eligibility criteria:
Inclusion Criteria:

Women aged 18 years or older
Subjects with newly diagnosed (early or advanced) breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status ≤2

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
Signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

Subject with resected primary tumour
Subjects with confirmed ductal carcinoma in situ
Men with breast cancer
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
Subjects who have received any therapy for breast cancer
Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration

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)
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
History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids
Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration
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
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
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