This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
pegylated liposomal doxorubicin (PLD) 30 mg/m\^2, i.v., d1, q3w
cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q3w
trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w
docetaxel (T) 90\~100 mg/m\^2, i.v., d1, q3w
docetaxel (T) 75 mg/m\^2, i.v., d1, q3w
carboplatin (Cb) AUC 6, i.v., d1, q3w
trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
RECRUITINGPathological complete response (pCR) rate
The percentage of participants without residual invasive cancer (ypT0/Tis ypN0 in the current AJCC staging system) when the complete resected breast specimen and all sampled regional lymph nodes were evaluated with hematoxylin and eosin staining after completion of systemic neoadjuvant therapy.
Time frame: Within 2 to 5 weeks after completion of neoadjuvant therapy
Objective response rate (ORR) at the end of neoadjuvant chemotherapy
The number of participants who achieved complete response and partial response at the end of neoadjuvant chemotherapy as a percentage of the overall evaluable participants.
Time frame: After the last dose to before surgery or within 21 days
5-year disease-free survival (DFS) rate
DFS is defined as the time from randomization to tumor recurrence or death from any cause. 5-year DFS rate is the percentage of participants with DFS from enrollment through 5 years.
Time frame: 5 years
Breast conservation rate at surgery
Percentage of participants receiving breast-conserving surgery after neoadjuvant therapy.
Time frame: Within 2 to 5 weeks after completion of neoadjuvant therapy
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0, including overall and Grade 3/4 adverse events.
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0, including overall and Grade 3/4 adverse events.
Time frame: 5 years
Percentage of Participants with dose reductions of chemotherapy due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Percentage of Participants with dose reductions of chemotherapy due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Time frame: 1 year
Percentage of Participants with chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Percentage of Participants with chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Time frame: 1 year
Relative dose intensity (RDI)
RDI=actual dose intensity\* / standard dose intensity# actual dose intensity\* = drug standard dose (mg/m\^2) / weeks of administration per cycle (week) standard dose intensity# = actual standard dose (mg/m\^2) / actual dosing weeks (week)
Time frame: 1 year
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