Trial Title:
Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer
NCT ID:
NCT05720026
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Trastuzumab
Pertuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
SYSA1901
Description:
loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle
Arm group label:
Treatment group
Other name:
pertuzumab biosimilar
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle
Arm group label:
Control group
Other name:
Perjeta®
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
loading dose of 8 mg/kg IV, followed by 6 mg/kg IV, q3w/cycle, total 4cycle
Arm group label:
Control group
Arm group label:
Treatment group
Other name:
Herceptin®
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
75 mg/m^2 IV, q3w/cycle, total 4cycle
Arm group label:
Control group
Arm group label:
Treatment group
Other name:
Docetaxel injection
Summary:
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence
study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs.
Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally
advanced HER2-positive and HR-negative breast cancer with a primary tumor > 2 cm.
Detailed description:
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence
study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs.
Perjeta® + trastuzumab + docetaxel in the patients with early-stage or locally advanced
HER2-positive and HR-negative breast cancer with a primary tumor > 2 cm. The eligible
patients will be randomized to treatment group (SYSA1901 + Trastuzumab + Docetaxel) or
control group (Perjeta® + Trastuzumab + Docetaxel) at 1:1 ratio. The stratification
factor is disease category (early-stage vs. locally advanced).
The primary endpoint is total pCR (tpCR). Secondary efficacy endpoints include breast pCR
(bpCR), objective response rate (ORR)，pharmacokinetic (PK) and immunogenicity.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zuo Wenjia, PhD
Phone:
+86-021-64175590-88603
Email:
wenjytuff@hotmail.com
Start date:
January 9, 2023
Completion date:
February 21, 2026
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720026
