The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin(PLD)plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation. This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
First phase PLD: 30mg/m2;35mg/m2;40mg/m2;IV, d1, q21d×6. Second phase PLD:MTD. IV, d1, q21d×6.
220mg/m2 IV for the first infusion,Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
Fei Ma
Beijing, Beijing Municipality, China
RECRUITINGPathological complete response(pCR) rate
Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery
Time frame: 5 months
Rate of Breast conserving surgery
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy
Time frame: 5 months
Rate of surgery
Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy
Time frame: 5 months
adverse events
Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: 5 months
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