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Spots Global Cancer Trial Database for Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Peking Union Medical College Hospital, Beijing, Beijing, China

Contact Details

Name: Sun Qiang, Master

Affiliation: PUMCH

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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