HER2-positive Breast CancerPhase 3NCT05720026
Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer
A Phase 3 study testing SYSA1901, Pertuzumab and Trastuzumab in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- SYSA1901, Pertuzumab and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2023to 21 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary agreement to provide written informed consent;
- Age ≥ 18 years;
- 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);
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- HER2 positive, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with In Situ Hybridization (ISH) positive;
- Estrogen receptor (ER) and progestin receptor (PR) negative; ER and PR negative is defined as < 1% nuclear staining;
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- Agree to receive surgical treatment of breast cancer at the participating unit when the surgical criteria are met after neoadjuvant therapy;
- Primary tumor size of > 2 cm in diameter;
- Left ventricular ejection fraction (LVEF)≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan;
- 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;
- Women of childbearing age must have a negative pregnancy test prior to the first dose;
- 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.
Who cannot join
- Stage IV (metastatic) breast cancer, inflammatory breast cancer, and bilateral breast cancer;
- Previous severe allergic reactions to any drug or its components in this trial (NCI-CTCAE 5.0 grade greater than 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);
- Major surgery and incomplete recovery within 4 weeks prior to the first dose of study drug;
- Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug;
- 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);
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- History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive, active syphilis;
- 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;
- Any uncontrollable complication, infection, or other condition that may affect study compliance or interfere with efficacy evaluation;
- History of drug abuse, or alcoholism, drug addicts;
- History of neurological or psychiatric disorders and poor compliance, such as epilepsy and dementia;
- Pregnant and breastfeeding women;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zuo Wenjia, PhD, +86-021-64175590-88603, wenjytuff@hotmail.com
About this study
Official title: 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 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.
Read the 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.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- SYSA1901, Pertuzumab, Trastuzumab, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYSA1901Drug
Also called pertuzumab biosimilar
loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle
PertuzumabDrug
Also called Perjeta®
loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle
TrastuzumabDrug
Also called Herceptin®
loading dose of 8 mg/kg IV, followed by 6 mg/kg IV, q3w/cycle, total 4cycle
DocetaxelDrug
Also called Docetaxel injection
75 mg/m^2 IV, q3w/cycle, total 4cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SYSA1901 combined with trastuzumab and docetaxel will be administrated intravenously on a 3-weekly schedule for 4 cycles (21 days per cycle). Receives: Drug: SYSA1901; Drug: Trastuzumab; Drug: Docetaxel |
| Control group | Active comparator | Perjeta® combined with trastuzumab and docetaxel will be administrated intravenously on a 3-weekly schedule for 4 cycles (21 days per cycle). Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathologic complete response (tpCR) assessed by Independent Review Committee（IRC）
The tpCR is defined as the histological evidence of no malignancy of lymph nodes in the regions of primary lesion and metastasis of breast cancer (i.e., ypT0/is, ypN0 in accordance with the AJCC staging system)
Measured: Up to 5 months
Secondary outcomes (7)
Percentage of patients with tpCR as assessed by the investigator
The tpCR is defined as the histological evidence of no malignancy of lymph nodes in the regions of primary lesion and metastasis of breast cancer (i.e., ypT0/is, ypN0 in accordance with the AJCC staging system)
Measured: Up to 5 months
Breast pathologic complete response (bpCR) assessed by IRC
The bpCR is defined as the histological evidence of no malignancy in the primary lesion of breast cancer, or only carcinoma in situ (i.e., ypT0/Tis, in accordance with current AJCC staging system).
Measured: Up to 5 months
Breast pathologic complete response (bpCR) assessed by the investigator
The bpCR is defined as the histological evidence of no malignancy in the primary lesion of breast cancer, or only carcinoma in situ (i.e., ypT0/Tis, in accordance with current AJCC staging system).
Measured: Up to 5 months
Percentage of patients with an objective response (BORR)
An objective response is defined as the percentage of patients who achieved a complete response or partial response as the best tumor response during the treatment period (that is, during Cycles 1-4 prior to surgery), as determined by the investigator on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Prior to surgery
Incidence of adverse event
Including type, incidence, severity, time and so on of adverse events
Measured: Up to approximately 30 months after randomization
Pharmacokinetic parameters of SYSA1901
To measure the serum concentration of SYSA1901 and pertuzumab (Perjeta ®) .
Measured: Up to approximately 30 months after randomization
Immunogenicity of SYSA1901
Anti-drug antibody (ADA) and neutralizing antibody (Nab) assessment
Measured: Up to approximately 30 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start9 Jan 2023
- Primary completion29 Aug 2025 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shao Zhimin, Professor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720026
- Sponsor's protocol ID
- SYSA1901-002
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05720026
- Acronym / sponsor ID
- SYSA1901-002
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SYSA1901, Drug: Trastuzumab, Drug: DocetaxelSYSA1901 combined with trastuzumab and docetaxel will be administrated intravenously on a 3-weekly schedule for 4 cycles (21 days per cycle). |
| Control group | Active comparator | Drug: Pertuzumab, Drug: Trastuzumab, Drug: DocetaxelPerjeta® combined with trastuzumab and docetaxel will be administrated intravenously on a 3-weekly schedule for 4 cycles (21 days per cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary agreement to provide written informed consent;
- Age ≥ 18 years;
- 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);
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- HER2 positive, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with In Situ Hybridization (ISH) positive;
Key exclusion criteria (13 listed)
- Stage IV (metastatic) breast cancer, inflammatory breast cancer, and bilateral breast cancer;
- Previous severe allergic reactions to any drug or its components in this trial (NCI-CTCAE 5.0 grade greater than 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);
- Major surgery and incomplete recovery within 4 weeks prior to the first dose of study drug;
- Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYSA1901Also: pertuzumab biosimilarloading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle | Drug | Treatment group |
| PertuzumabAlso: Perjeta®loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle | Drug | Control group |
| TrastuzumabAlso: Herceptin®loading dose of 8 mg/kg IV, followed by 6 mg/kg IV, q3w/cycle, total 4cycle | Drug | Control group, Treatment group |
| DocetaxelAlso: Docetaxel injection75 mg/m^2 IV, q3w/cycle, total 4cycle | Drug | Control group, Treatment group |
Primary outcome
Total pathologic complete response (tpCR) assessed by Independent Review Committee（IRC）
Time frame: Up to 5 months
The tpCR is defined as the histological evidence of no malignancy of lymph nodes in the regions of primary lesion and metastasis of breast cancer (i.e., ypT0/is, ypN0 in accordance with the AJCC staging system)
7 secondary outcomes
Percentage of patients with tpCR as assessed by the investigator
Time frame: Up to 5 months
Breast pathologic complete response (bpCR) assessed by IRC
Time frame: Up to 5 months
Breast pathologic complete response (bpCR) assessed by the investigator
Time frame: Up to 5 months
Percentage of patients with an objective response (BORR)
Time frame: Prior to surgery
Incidence of adverse event
Time frame: Up to approximately 30 months after randomization
Pharmacokinetic parameters of SYSA1901
Time frame: Up to approximately 30 months after randomization
Immunogenicity of SYSA1901
Time frame: Up to approximately 30 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shao Zhimin, Professor study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYSA1901, Pertuzumab and Trastuzumab in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao Zhimin, Professor (+86-021-64175590-88603, szm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathologic complete response (tpCR) assessed by Independent Review Committee（IRC） (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.