RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID

Inclusion Criteria

• •Histologically confirmed invasive adenocarcinoma triple negative breast cancer (TNBC), pT1cN0M0 - anyTanyNM0 confirmed by physical examination or imaging
• •Triple negative breast cancer was defined as:
• •* HER2 negative
• •* IHC 0-1+
• •* IHC 2+ and FISH negative (ratio \< 2.0 or \< 4 gene copies / cell, as per new ASCO guideline)
• •* ER and PR negative confirmed\< 1%
• •For patients with surgery of primary tumor followed by adjuvant chemotherapy, treatment with IVAC\_W\_bre1\_uID was initiated after completion of the adjuvant chemotherapy. The adjuvant chemotherapy should contain anthracyclines and taxanes - except for patients with contraindications for treatment with one or both substances.
• •For patients with neoadjuvant chemotherapy according to local standard followed by surgery of primary tumor, treatment with IVAC\_W\_bre1\_uID was initiated after the surgery. The neoadjuvant chemotherapy should contain anthracyclines and taxanes - except for patients with contraindications for treatment with one or both substances.
• •Patients with planned radiotherapy (as per local policy) were eligible and should be irradiated in parallel to the vaccination cycles
• •Patients after completion of standard of care therapy e. g. surgery and/or chemotherapy and/or radiotherapy (as per local policy) were eligible at the discretion of the investigator after no clinical sings of recurrence and/or metastasis, if the treatment with IVAC\_W\_bre1\_uID starts within one year after completion of the radiotherapy.
• •Adequate organ function (hematopoietic, hepatic and renal function):
• •* Hemoglobin ≥ 9 g/dl
• •* ANC ≥ 1500/µl
• •* Platelet count ≥ 100,000/mm³
• •* ALT/AST \<2 x ULN
• •* Serum creatinine ≤ 1.5 ULN
• •Expression of at least two tumor-specific antigens of the WAREHOUSE\_bre1 confirmed by RT-qPCR on FFPE tumor tissue for ARM1 and ARM3
• •Female patients, ≥ 18 years of age
• •Written informed consent
• •ECOG performance status (PS) 0-1
• •Recovered pre-existing toxicities \< grade 2 according to NCI CTCAE 4.03, except alopecia
• •Negative pregnancy test (measured by β-HCG) for females of childbearing age
• •Not pregnant or nursing