Real World Study on the Efficacy and Safety of Anti-HER2 Therapy

Arms (0)

Primary outcomes (3)

1. measure

   Objective Response Rate (ORR)

   timeFrame

   From date of randomization until the date at the end of the second treatment cycle (42 days)

   description

   The total rate of CR+PR after the completion of two cycles of treatment.

2. measure

   Progression-Free Survival (PFS)

   timeFrame

   From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

   description

   The survival time from the date of recruitment to the date of the first documented progression or date of death.

3. measure

   Adverse Events

   timeFrame

   From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

   description

   All adverse events \[including adverse events (AE / SAE) and ADR (adverse drug reactions)\] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.