This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity
Fudan University Shanghai Cancer Center
Shanghai, China
Pathological complete response rate
The percentage of patients with a pathological complete response after neoadjuvant therapy
Time frame: Obtained within six months of the last patient's enrollment
Overall response rate
The percentage of patients with complete response or partial response after neoadjuvant therapy
Time frame: Obtained within six months of the last patient's enrollment
Three-year disease free survival
The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery
Time frame: Obtained within 42 months after last patient's enrollment
Overall survival
The overall survival time of all patients enrolled in the study presented by survival curve and median value
Time frame: Obtained around 5 years after the last patient's erollment
Safety
List and frequencies of adverse events occured during and one-month after the investigational drug treatment
Time frame: Obtained around six months after the last patient's enrollment
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