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Brief Title: Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer
Official Title: Safety and Efficacy Evaluation of Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer
Study ID: NCT01413828
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Peking Union Medical College Hospital, Beijing, Beijing, China
Name: Sun Qiang, Master
Affiliation: PUMCH
Role: STUDY_CHAIR