• Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.

• Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologist (CAP) guidelines .

• The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.

• Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus.

• Measurable disease in the breast with at least one lesion with a diameter ≥ 1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable.

• Male or female subject Age ≥ 18 years.

• ECOG performance status 0-1

• Adequate bone marrow function (administration of G-CSF, EPO and/or blood transfusion within 14 days before registration is not allowed):

‣ neutrophil count ≥ 1.5 x 109/L

⁃ platelet count ≥ 100 x 109/L

⁃ hemoglobin ≥ 90 g/L

• Adequate hepatic function:

‣ total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 x ULN

⁃ AST and ALT ≤ 2.5 x ULN,

⁃ Albumin 30 ≥ g/L

⁃ Lactate Dehydrogenase (LDH) \<2.5 ULN

• Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m2 (according to CKD-EPI formula)

• Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiography (ECHO)

• Adequate coagulation function:

‣ INR ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy

⁃ aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy

⁃ If the patient is receiving anticoagulant therapy, the treating physician must determine that the anticoagulation can be stopped at least 24 hours prior to injection.

• Women of childbearing potential must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 7 months after the last dose of INT230-6 or 6 months after standard of care treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. (www.swissmedicinfo.ch).

• Men agree not to donate sperm or to father a child by using effective contraception during trial treatment and until 6 months after the last dose of INT230-6 or standard of care treatment (www.swissmedicinfo.ch).