Triple Negative Breast CancerPhase 3NCT07879911
A Study of SYS6043 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Recurrent or Metastatic Triple-Negative Breast Cancer
A Phase 3 study testing Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043 and Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin） in people with Triple Negative Breast Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
This is a randomized, controlled, open-label, multicenter study. Eligible participants are patients with unresectable locally recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043 and Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin）
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 May 2029
- Phase
- Phase 3
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form, with no restriction on sex.
- Histologically and/or cytologically confirmed triple negative breast cancer (TNBC) meeting both of the following criteria: a) Human epidermal growth factor receptor 2 (HER2) negative; b) Estrogen receptor (ER) negative and progesterone receptor (PR) negative.
- De novo metastatic disease, or unresectable recurrent and/or metastatic disease occurring after completion of curative intent therapy.
- No prior systemic anti tumor therapy for unresectable recurrent or metastatic disease.
- PD L1 expression determined by the sponsor designated central laboratory using tumor tissue collected at screening. Participants must meet either: a) PD L1 negative expression (CPS < 10); OR b) PD L1 positive expression (CPS ≥ 10).
- At least one measurable lesion per RECIST version 1.1.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of at least 12 weeks.
- Deemed by the investigator to be suitable for one of the investigator's choice chemotherapy regimens (paclitaxel, nab paclitaxel, capecitabine, eribulin, or carboplatin).
- Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony stimulating factor within 2 weeks prior to randomization).
- Participants must have recovered from all toxicities attributable to prior therapies (recovered to Grade ≤ 1 per CTCAE Version 6.0, or otherwise meeting protocol specified entry criteria).
- Serum pregnancy test negative within 7 days prior to randomization for women of child bearing potential.
- Voluntarily agrees to participate in this study, provides signed informed consent, and is able to comply with protocol required visits and procedures.
Who cannot join
- Diagnosis of another malignancy within 3 years prior to randomization.
- Presence of spinal cord compression, clinically active brain metastase.
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular cerebrovascular risk factors.
- 4 History of non infectious interstitial lung disease (ILD) or non infectious pneumonitis requiring steroid therapy.
- 5 Clinically significant pulmonary impairment secondary to underlying pulmonary disease.
- 6 Tumor invasion into adjacent vital organs and blood vessels. 7 Severe infection occurring within 4 weeks prior to randomization. 8 History of esophageal and gastric varices, severe ulcer, gastrointestinal perforation, gastrointestinal obstruction, intra abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to randomization.
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- 9 Active or well documented prior history of inflammatory bowel disease. 10 Uncontrolled systemic disease as judged by the investigator. 11 Participants with active viral hepatitis; positive hepatitis C virus (HCV) with HCV RNA above the lower limit of quantification of the assay.
- 12 Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- 13 Known hypersensitivity to active pharmaceutical ingredients or excipients of study drug.
- 14 Known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 15 Pregnant or breastfeeding women. 16 Prior receipt of B7 H3 targeted therapy; prior irinotecan, topotecan, or any chemotherapy agents targeting topoisomerase I (including ADCs).
- 17 Prior treatment with the same agent as the investigator selected chemotherapy.
- 18 Live vaccine administered within 4 weeks before randomization, or planned administration of live vaccine during study treatment.
- 19 Insufficient washout period for prior anti tumor therapy before the first dose of study drug.
- 20 Chronic concomitant use of systemic corticosteroids or other immunosuppressive agents.
- 21 Local or systemic disease unrelated to malignancy, or diseases/symptoms secondary to tumor.
- 22 Any condition that, in the investigator's opinion, would interfere with the evaluation of study drug, participant safety, or interpretation of study results, or any other condition rendering the participant unsuitable for study participation as assessed by the investigator.
- 23 Systemic administration of strong CYP3A4 / CYP2C8 inhibitors or strong inducers, or OATP1B1 / OATP1B3 inhibitors within 14 days prior to the first dose of study drug, or requiring continued systemic use of such agents during study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-Label, Multicenter Phase III Study of SYS6043 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
This is a randomized, controlled, open-label, multicenter study. Eligible participants are patients with unresectable locally recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy. Participants may be PD-L1 negative; or PD-L1 positive with disease recurrence after PD-1/PD-L1 inhibitor therapy in the neoadjuvant/adjuvant setting; or PD-L1 positive who cannot tolerate PD-1/PD-L1 inhibitor therapy due to other underlying comorbidities.
Approximately 550 participants will be enrolled and randomized at a 1:1 ratio to the experimental group or the control group. All enrolled participants will continue study treatment until BICR-confirmed disease progression, no further clinical benefit as judged by the investigator, unacceptable toxicity, withdrawal of informed consent, loss to follow-up, death, or end of study, whichever occurs first.
Upon discontinuation of study treatment, participants will complete the end-of-treatment (EOT) visit and safety follow-up. Survival visits will be performed every 3 months (±14 days) after the last study drug administration to collect participants' survival status and information regarding subsequent anti-tumor therapies
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043, Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin）
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043Biological
Add details that will distinguish this intervention from other interventions in this or another clinical study.
Participants in the experimental group will receive SYS6043, administered on Day 1 of each cycle，Q3W.
Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin）Drug
Add details that will distinguish this intervention from other interventions in this or another clinical study.
Paclitaxel (90 mg/m², intravenous, Days 1, 8, and 15 of each 4 week cycle [Q4W]; or 80 mg/m², intravenous, Days 1, 8, and 15 of each 3 week cycle [Q3W]); Nab paclitaxel (100 mg/m², intravenous, Days 1, 8, and 15, Q4W); Capecitabine (1000 1250 mg/m², orally, twice daily on Days 1 14, Q3W); Eribulin (1.4 mg/m², intravenous, Days 1 and 8, Q3W); Carboplatin (administered on Day 1 at an area under the curve [AUC] of 6, Q3W).
| Study group | Role | What they receive |
|---|---|---|
| SYS6043 | Experimental | Not described Receives: Biological: Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043 |
| Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin） | Active comparator | Not described Receives: Drug: Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Assessed by BICR per RECIST 1.1
Progression free survival is defined as the time from randomization to the first documented disease progression per RECIST version 1.1 or death from any cause, whichever occurs first. Disease progression is centrally reviewed by a blinded independent imaging review committee to eliminate assessment bias.
Measured: Up to approximately 5 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. For participants who are not deceased, survival time will be censored at the last known date the participant was known to be alive.
Measured: Up to approximately 5 years
Secondary outcomes (9)
Objective Response Rate (ORR) assessed by BICR/Investigator per RECIST 1.1
Objective Response Rate (ORR) is the proportion of participants achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1. ORR will be evaluated by both Blinded Independent Central Review (BICR) and investigator (INV).
Measured: Up to approximately 5 years
Disease Control Rate (DCR) assessed by BICR/Investigator per RECIST 1.1
Disease Control Rate (DCR) is defined as the percentage of participants with confirmed complete response (CR), partial response (PR), or stable disease (SD) per RECIST version 1.1. DCR will be evaluated by both Blinded Independent Central Review (BICR) and investigator (INV).
Measured: Up to approximately 5 years
Duration of Response (DoR) assessed by BICR/Investigator per RECIST 1.1
Duration of Response (DoR) is defined as the time from the date of first documented confirmed objective response (CR or PR) per RECIST version 1.1 to the date of documented disease progression or death from any cause, whichever occurs first. DoR will be evaluated by both Blinded Independent Central Review (BICR) and investigator (INV)
Measured: Up to approximately 5 years
Time To Response (TTR) assessed by BICR/Investigator per RECIST 1.1
Time To Response (TTR) is defined as the time from randomization to the date of first documented confirmed objective response (CR or PR) per RECIST version 1.1 among participants who achieve an objective response. TTR will be evaluated by both Blinded Independent Central Review (BICR) and investigator (INV).
Measured: Up to approximately 5 years
Time to First Subsequent Therapy(TFST)
Time to First Subsequent Therapy (TFST) is defined as the time from randomization to the start date of the first subsequent anti-cancer therapy after discontinuation of randomized study treatment, or death from any cause, whichever occurs first.
Measured: Up to approximately 5 years
Time to Second Subsequent Therapy (TSST)
Time to Second Subsequent Therapy (TSST) is defined as the time from randomization to the start date of the second subsequent anti-cancer therapy after discontinuation of randomized study treatment, or death from any cause, whichever occurs first.
Measured: Up to approximately 5 years
Incidence and Titer of Anti Drug Antibody (ADA) against SYS6043, and Incidence of Neutralizing Antibody (NAb), if applicable
The incidence and titer of anti drug antibody (ADA) against SYS6043 will be evaluated from serum samples. The incidence of neutralizing antibody (NAb) will be assessed among ADA positive participants, if applicable.
Measured: Up to approximately 5 years
Patient-Reported Quality of Life Scores Evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Participants' quality of life will be assessed using the symptom domain scales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item patient-reported questionnaire. All transformed subscale scores range from 0 to 100. For the functional scales and global health status scale, higher scores represent better functioning and quality of life. For symptom scales, higher scores indicate more severe symptoms (worse outcome).
Measured: Up to approximately 5 years
Patient Reported Quality of Life Scores Evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 42(EORTC QLQ BR42).
Participants' quality of life will be assessed using the symptom domain scales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 42 (EORTC QLQ-BR42). This is a 42-item breast cancer-specific patient-reported questionnaire. All transformed subscale scores range from 0 to 100. For functional scales, higher scores represent better functioning. For symptom scales, higher scores indicate more severe symptoms (worse outcome）
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized, open-label, parallel-group, active-controlled study with a permitted crossover design. Participants are randomly assigned in a 1:1 ratio to receive either SYS6043 or investigator's choice of chemotherapy. Participants in the control arm who experience first disease progression may crossover to receive SYS6043 treatment if eligibility criteria are met. Participants in the experimental arm will not crossover after disease progression.
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879911
- Sponsor's protocol ID
- SYS6043-006
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No