Breast Cancer Clinical Trial
Official title:
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer: a Single-arm, Ahead, Open-label Study
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+
Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control
group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.
It is proposed that 100 participants will be enrolled in this study. The target population is
women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic
therapy.
The primary objective of the trial is to determine the pCR rate. The secondary objective of
the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance
Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
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