Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Most of the published data support the preferential use of an anthracycline-containing
adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and
trastuzumab, however, are contraindicated due to the observation of unacceptably high rates
of cardiotoxicity in a large randomized trial in the metastatic setting. However, in
neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy
regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All
large adjuvant trials have evaluated only the sequential strategy of administering
anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an
anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting.
Given the similar patients characteristics, the investigators hypothesize that trastuzumab
concurrently with an anthracycline-containing chemotherapy regimen would not increase
cardiotoxicity but efficacy.