HER-2 Positive Breast Cancer Clinical Trial
Official title:
Multicenter, Randomized, Open-label Phase II Study to Compare the Efficacy and Safety of Trastuzumab and Paclitaxel Based Regimen Plus Carboplatin or Epirubicin as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients
The purpose of the investigators study is to compare the efficacy and safety of combining trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant treatment. The main end point of this study would be the efficacy and safety of the two treatment arms, and the trend of the two curves is anticipated.
With the increased awareness and development of the diagnosis of breast cancer, more and
more breast cancer is diagnosed at early. Amplification or overexpression, or both, of human
epidermal growth factor receptor-2 (HER2, also known as ERBB2), a transmembrane receptor
tyrosine kinase, is present in around 22% of early breast cancers, 35% of locally advanced
and metastatic tumors, and 40% of inflammatory breast cancers, and is associated with
aggressive disease and poor prognosis. The significant efficacy and good safety profile of
Trastuzumab targeting HER 2 combination with chemotherapy as adjuvant treatment on EBC are
accepted. Currently Trastuzumab has moved to Neoadjuvant treatment combined with
chemotherapy based on many publications, among them pCR is accepted as primary endpoint to
evaluate the efficacy of neoadjuvant therapy.
In the investigators study, Trastuzumab was concomitantly administered with different
chemotherapies after randomization to determine the effect of this approach on the
pathologic CR rates. 100 patients from multicenter would be randomly assigned into two
treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant
treatment. Pathological complete response rate (pCR), disease free survival (DFS), response
rates (RR), percentage of conserving breast surgery and adverse events including Serious AEs
and non-serious AEs would be compared. The follow up time for each patients would be 3 years
at most.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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