The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
In order to compare the effects of nab-PHP and TCbHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen： the neoadjuvant chemotherapy with 6\*nab-PHP regimen group (experimental group): nab-paclitaxel 125mg/m2 on days 1, 8, and 15 every 21 days as one cycle; 6\*TCbHP regimen (control group): docetaxel 75 mg/m2 + carboplatin (AUC=6) on day 1. Both groups will receive trastuzumab (loading dose 8 mg/kg followed by a maintenance dose of 6 mg/kg) on day 1 and pertuzumab (loading dose 840 mg followed by a maintenance dose of 420 mg) on day 1, every 21 days as one cycle. Surgery will be performed after completion of neoadjuvant chemotherapy, with intraoperative excision of specimens (breast + axilla) for pathological evaluation. Comparative analysis of pCR, EFS, iDFS and safety outcomes between the two groups will be conducted using appropriate statistical methods. Safety evaluation will include the incidence of adverse events, incidence of serious adverse events, dose adjustment rate, and discontinuation rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
688
Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGPathological Complete Response (pCR)
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Time frame: through study completion, an average of 1 year
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression during neoadjuvant treatment, disease recurrence, or any cause of death.
Time frame: 5 years after surgery
Invasive Disease-Free Survival (iDFS)
This refers to the time from surgery to the first documented occurrence of an event such as ipsilateral invasive breast tumour recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Time frame: 5 years after surgery
Safety-Number of adverse events and serious adverse events.
Safety will be assessed by evaluating the nature, incidence, and severity of chemotherapy-related adverse events according to CTCAE 4.0 (Common Terminology Criteria for Adverse Events).
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Tolerability will be assessed by evaluating the dose adjustment rate and discontinuation rate of chemotherapy drugs in both treatment regimens.
Time frame: After the end of the 6th cycle of chemotherapy (21 days as 1 cycle)
Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.
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The differences in pCR rate between various predefined subgroups and the factors affecting pCR in the enrolled population will be explored.
Time frame: through study completion, an average of 1 year