Neoplasms, Breast Clinical Trial
Official title:
A Prospective, Open-label，Multicentre，Real-word Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as Neoadjuvant Therapy for Women With HER2-positive and p95HER2-positive，PI3K Mutation，or PTEN Loss Breast Cancer
This is a prospective, open-label, real-word study evaluating the efficacy and safety of
lapatinib in combination with chemotherapy versus trastuzumab in combination with
chemotherapy in women with HER2-positive and p95HER2-positive ,or PI3K mutation, or PTEN loss
breast cancer . Eligible subjects will have newly diagnosed breast cancer (Stage II-III) ;
not have received systemic or local treatment . The primary endpoint was the rate of
pathological complete response (pCR). The secondary objectives are to evaluate overall
survival, overall response rate, clinical benefit response rate and the safety as well as
tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.
Patients will receive lapatinib 1000 mg daily or trastuzumab 4 mg/kg intravenous (IV) load
followed by 2 mg/kg IV weekly for a total of 12 weeks. After surgery, patients planned total
duration of the anti-HER2 therapy will be one year.
n/a
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