Metastatic Breast Cancer Clinical Trial
Official title:
A Randomized, Open-label Study of First Line Pyrotinib, Trastuzumab With an Aromatase Inhibitors, in the Treatment of HER2 Positive and HR Positive Metastatic or Inoperable Locally Advanced Breast Cancer
This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.
This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is
to compare that PFS of patients with trastuzumab, AI plus pyrotinib and trastuzumab plus an
AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer
(LABC).
Eligible patients will randomized to a ratio of 1:1 to pyrotinib+ trastuzumab + aromatase
inhibitor (experimental group) or trastuzumab+aromatase inhibitor (control group).
Stratification factors were 1)time since adjuvant hormone therapy (<=12 months/＞12 months/no
prior hormone therapy); 2) lesion (visceral; non-visceral).
In treatment period, patients will be administrated trastuzumab plus aromatase inhibitors,
with or without pyrotinib, every 21 days for 1 cycle, until disease progression, toxicity
intolerance, withdrawal of informed consent, patients judged must be terminated study
termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
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