The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
812
Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)
Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.
Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGPathological Complete Response (pCR)
Time frame: through study completion, up to 6 months
Event-Free Survival (EFS)
Time frame: 5 years after surgery
Invasive Disease-Free Survival (iDFS)
Time frame: 5 years after surgery
Safety-Number of adverse events and serious adverse events.
Time frame: up to 1 year
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Time frame: up to 1 year
Residual Cancer Burden (RCB)
Proportion of patients with residual cancer burden score of 0-1 after surgery
Time frame: up to 6 months
EORTC QLQ-C30 score
quality of life evaluated by EORTC QLQ-C30
Time frame: up to 1 year
EORTC QLQ-BR23 score
quality of life evaluated by EORTC QLQ-BR23
Time frame: up to 1 year
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