Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer

NCT07095023 | Recruiting

• 1 other identifier: SYSKY-2025-397-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.

Conditions

Breast Cancers

Outcome Measures

Primary Outcomes (1)

• Total Pathological Complete Response(tpCR)

  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).

  Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)

Secondary Outcomes (5)

• Overall Response Rate(ORR)

  Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)

• Event-Free Survival (EFS)

  Up to 3 years

• Overall survival(OS)

  Up to 3 years

• Health Related Quality of Life (QoL)

  From baseline to 30 days after completion of treatment or the last follow-up visit

• Adverse Events

  From first dose of study drug to 30 days after completion of treatment

Study Arms (1)

Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab

EXPERIMENTAL

Paclitaxel oral solution plus subcutaneous fixed-dose combination of pertuzumab and trastuzumab

Drug: Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab

Interventions

Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab DRUG

Patients who meet the inclusion criteria will be enrolled and given paclitaxel oral solution and subcutaneous pertuzumab/trastuzumab for neoadjuvant treatment. Paclitaxel oral solution: 200mg/m2 po bid, D1,D8,D15, q3w. Subcutaneous pertuzumab/trastuzumab: 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, q3w.

Also known as: DHP107, RMX3001, Liporaxel, pertuzumab, trastuzumab, and hyaluronidase-zzxf

Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).
• Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN
• Blood urea nitrogen and serum creatinine ≤1.5×ULN
• Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent

You may not qualify if:

• History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
• Prior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.
• Participation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and/or receipt of investigational drug/device during the trial.
• Major surgery within 28 days prior to the first dose or planned major surgery during the study period.
• History of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.
• Active tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.
• History of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.
• History of cardiovascular or cerebrovascular diseases, including:
• Unstable angina;
• Clinically significant arrhythmias requiring medication;
• Myocardial infarction within the past 6 months;
• Heart failure or second-degree or higher atrioventricular block;
• Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.
• Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.
• Unsuitability for oral administration of the investigational drug, as judged by the investigator, including:

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Peking University Cancer Hospital & Institute: collaborator
• Hainan People's Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Guangdong Women and Children Hospital: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

Study Sites (9)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Guangdong Women and children Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

NOT YET RECRUITING

Guangxi Provincial Cancer Hospital

Nanning, Guangxi, China

NOT YET RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

NOT YET RECRUITING

Hainan Central Hospital

Haikou, Hainan, China

NOT YET RECRUITING

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Peking University Shenzhen Hospita

Shenzhen, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Qiang Liu, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Liu, PhD

CONTACT

86-13922251256; liuqiang_sysu@163.com

Yudong Li, PhD

CONTACT

86+15989295289; 649046236@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 31, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)