Neoplasms

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Breast Neoplasms

Breast Diseases

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Docetaxel

Trastuzumab

Pertuzumab

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Liposomal doxorubicin

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Antineoplastic Agents, Alkylating

Alkylating Agents

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Antineoplastic Agents, Immunological

pegylated liposomal doxorubicin (PLD) 30 mg/m\^2, i.v., d1 + cyclophosphamide (C) 600 mg/m\^2, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 followed by docetaxel (T) 90\~100 mg/m\^2, i.v., d1 + trastuzumab (H) 6 mg/kg, i.v., d1 + pertuzumab (P) 420 mg, i.v., d1 q3w, for 4 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery.

docetaxel (T) 75 mg/m\^2, i.v., d1 + carboplatin (Cb) AUC 6, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 q3w, for 6 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery.

pegylated liposomal doxorubicin (PLD) 30 mg/m\^2, i.v., d1, q3w

pegylated liposomal doxorubicin (PLD)

cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q3w

cyclophosphamide (C)

trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w

trastuzumab (H)

pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w

pertuzumab (P)

docetaxel (T) 90\~100 mg/m\^2, i.v., d1, q3w

docetaxel (T)

carboplatin (Cb)

Qiang Liu, PhD

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.

Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

Subgroup analysis of pathological complete response (pCR) rates based on clinically relevant baseline characteristics

To explore the biomarkers and mechanisms related to neoadjuvant therapy using high-throughput sequencing technology (NGS), and to screen the patients who are suitable for anthracycline-containing neoadjuvant therapy

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.

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.

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.

Percentage of participants receiving breast-conserving surgery after 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.

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 chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0

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)

Spots Global Cancer Trial Database for trastuzumab (h)