A Phase 3 interventional study of 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 Triple Negative Breast Cancer, sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's planned enrollment of 550 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →CSPC Megalith Biopharmaceutical Co.,Ltd. is the lead sponsor of 38 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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.
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.
Biological: Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043
Drug: Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin）
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.
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).
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.
Time frame: 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.
Time frame: Up to approximately 5 years
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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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）
Time frame: Up to approximately 5 years
Correlation Between Efficacy and Expression Levels of Biomarkers Including B7 H3
Exploratory analysis will be performed to evaluate the correlation between tumor biomarker expression levels including B7 H3 and anti tumor efficacy endpoints
Time frame: Up to approximately 5 years
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 62 phase 3 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 96. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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