Comparing SYSA1901 to Perjeta® for HER2-Positive Breast Cancer

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab (Perjeta®) in the Neoadjuvant Therapy of HER2-Positive Breast Cancer

This study is testing whether a new treatment called SYSA1901 works as well as Perjeta® for people with early-stage or locally advanced HER2-positive breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, trastuzumab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05720026 on ClinicalTrials.gov

What this trial studies

This phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study aims to evaluate the efficacy and safety of SYSA1901 combined with trastuzumab and docetaxel against Perjeta® combined with trastuzumab and docetaxel in patients with early-stage or locally advanced HER2-positive and HR-negative breast cancer. Participants will be randomly assigned to one of the two treatment groups in a 1:1 ratio, with the primary endpoint being total pathological complete response (tpCR). Secondary endpoints will assess additional efficacy measures, pharmacokinetics, and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with early-stage or locally advanced HER2-positive and HR-negative breast cancer and a primary tumor larger than 2 cm.

Not a fit: Patients with hormone receptor-positive breast cancer or those with a primary tumor size of 2 cm or less may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with HER2-positive breast cancer.

How similar studies have performed: Other studies have shown success with similar approaches in treating HER2-positive breast cancer, indicating potential for this study's success.

Eligibility criteria

Inclusion Criteria:

1. Voluntary agreement to provide written informed consent;
2. Age ≥ 18 years;
3. Histologically confirmed invasive breast carcinoma, and breast cancer staging \[in accordance with the American Joint Committee on Cancer (AJCC) staging system (8th edition)\]: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2-3, M0; T4, any N, M0);
4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
5. HER2 positive, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with In Situ Hybridization (ISH) positive;
6. Estrogen receptor (ER) and progestin receptor (PR) negative; ER and PR negative is defined as \< 1% nuclear staining;
7. Agree to receive surgical treatment of breast cancer at the participating unit when the surgical criteria are met after neoadjuvant therapy;
8. Primary tumor size of \> 2 cm in diameter;
9. Left ventricular ejection fraction (LVEF)≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan;
10. Adequate major organ function, meeting the following criteria (have not received blood transfusion, EPO,G-CSF, other hematopoietic stimulating factors or medical supportive treatments within 14 days before the first dose of study drug): absolute neutrophil count (ANC) ≥1.5×10\^9 /L; Leukocyte count≥3.0×10\^9 /L, platelet (PLT) ≥100×10\^9 /L; hemoglobin ≥90 g/L; Serum creatinine ≤ 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin ≤1.5×ULN; international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, or activated partial thromboplastin time (APTT) ≤1.5×ULN (not receiving anticoagulation), or patients receiving anticoagulation need to be within treatment target range and at a stable dose;
11. Women of childbearing age must have a negative pregnancy test prior to the first dose;
12. Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer, inflammatory breast cancer, and bilateral breast cancer;
2. Previous severe allergic reactions to any drug or its components in this trial (NCI-CTCAE 5.0 grade greater than 3);
3. Patients with any other malignant tumor within 2 years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer and other malignant tumors that have been radically removed and have not recurred);
4. Major surgery and incomplete recovery within 4 weeks prior to the first dose of study drug;
5. Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug;
6. Received chemotherapy, endocrine therapy, anti-HER2 biological therapy, breast surgery or local radiotherapy for breast cancer (except for diagnostic biopsy surgery or benign breast tumor surgery);
7. History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive, active syphilis;
8. History of severe cardiovascular disease, including previous coronary artery bypass grafting or coronary stent implantation, myocardial infarction or cerebrovascular accident within 6 months, history of congestive heart failure or unstable angina pectoris, uncontrolled severe hypertension and arrhythmia requiring drug treatment;
9. Any uncontrollable complication, infection, or other condition that may affect study compliance or interfere with efficacy evaluation;
10. History of drug abuse, or alcoholism, drug addicts;
11. History of neurological or psychiatric disorders and poor compliance, such as epilepsy and dementia;
12. Pregnant and breastfeeding women;
13. Other conditions that may affect the assessment of the primary endpoint or render the patient inappropriate for entry into this study in the opinion of the investigator.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Shao Zhimin, Professor

Conditions HER2-positive Breast Cancer