Study study type PathologyT1T0Patientssample sizesROB Results

es-BC - HER2 negative - (neo)adjuvant (NA) breast cancer HER 2 negative es-BC - HER2 negative - (neo)adjuvant (NA)

versus paclitaxel followed by doxorubicin plus cyclophosphamide
pembrolizumab plus paclitxel followed by doxorubicin plus cyclophosphamide
I-SPY2, 2020
  NCT01042379
RCTes-BC - HER2 negative - (neo)adjuvant (NA)pembrolizumab plus paclitxel followed by doxorubicin plus cyclophosphamidepaclitaxel followed by doxorubicin plus cyclophosphamidePatients with ERBB2 (formerly HER2)-negative breast cance, women treated with neoadjuvant for early-stage breast cancer (stage II or III)69 / 181high
inconclusive
  • suggested 2.7-fold increase in pCR (PE)

mBC - HER 2 negative breast cancer HER 2 negative mBC - HER 2 negative

versus Standard of Care (SoC)
durvalumab alone
Saphir02 Breast-Immuno, 2021
  NCT02299999
RCTmetastatic/advanced - breast cancer (mBC)durvalumabchemotherapypatients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after initial chemotherapy (maintenance chemotherapy).131 / 68some concern
inconclusive
  • inconclusive 40 % increase in progression or deaths (PFS) (PE)
Maintenance chemotherapy was more effective than durvalumab in patients with hormone receptor-positive and Her2-negative disease.