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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)

CSPC Ouyi Pharmaceutical Co., Ltd.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days

Docetaxel and Cyclophosphamide (TC)

Docetaxel (T)

Leiping Wang, MD

Zhonghua Wang, MD

The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer

Relationship of serum VEGF level and efficacy

Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy

To evaluate the relationship of genetic polymorphisms and efficacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05159193	Breast Cancer	pegylated lipos... cyclophosphamid... trastuzumab (H) pertuzumab (P) docetaxel (T) docetaxel (T) carboplatin (Cb... trastuzumab (H) pertuzumab (P)	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer	NCT01526499	Breast Cancer	Docetaxel and C... Docetaxel (T)	18 Years - 70 Years	Fudan University

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