Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

versus trastuzumab plus chemotherapy
margetuximab plus chemotherapy
SOPHIA, 2021
  NCT02492711
RCTla/mBC - HER2 positive - 2nd Line (L2)margetuximab plus chemotherapy (capecitabine or eribulin or gemcitabine or vinorelbine)trastuzumab plus chemotherapy (capecitabine or eribulin or gemcitabine or vinorelbine)Patients with confirmed ERBB2-positive advanced BC by local or optional central testing of themost recent biopsy, and must have had progressive disease after 2 or more lines of prior ERBB2 targeted therapy (including pertuzumab) and 1 to 3 lines of nonhormonal metastatic BC therapy.266 / 270some concern
conclusif
  • inconclusive 11 % decrease in deaths (OS) (PE)
  • demonstrated 24 % decrease in progression or deaths (PFS) (PE)
  • inconclusive 49 % increase in objective responses (ORR) (PE)