Metastatic Breast Cancer Clinical Trial
Official title:
Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the First-line Treatment of Advanced HER2-positive/HR-positive Breast Cancer Phase II Study
This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.
This is a exploratory, single-arm, open-label,multicenter phase II trial. Our primary purpose
is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive
and hormone receptor-positive MBC or locally advanced breast cancer (LABC).
In treatment period, patients will be administrated pyrotinib plus trastuzumab and aromatase
inhibitors, 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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