Trial · NCT07879911
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
NCT07879911, Phase 3, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07879911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07879911
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07879911
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 550 participants, estimated
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Conditions
- Triple Negative Breast Cancer
- Interventions
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）
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Assessed by BICR per RECIST 1.1 | Up to approximately 5 years | 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. |
| Primary | Overall Survival (OS) | Up to approximately 5 years | 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. |
| Secondary | Objective Response Rate (ORR) assessed by BICR/Investigator per RECIST 1.1 | Up to approximately 5 years | 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). |
| Secondary | Disease Control Rate (DCR) assessed by BICR/Investigator per RECIST 1.1 | Up to approximately 5 years | 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). |
| Secondary | Duration of Response (DoR) assessed by BICR/Investigator per RECIST 1.1 | Up to approximately 5 years | 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) |
| Secondary | Time To Response (TTR) assessed by BICR/Investigator per RECIST 1.1 | Up to approximately 5 years | 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). |
| Secondary | Time to First Subsequent Therapy(TFST) | Up to approximately 5 years | 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. |
| Secondary | Time to Second Subsequent Therapy (TSST) | Up to approximately 5 years | 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. |
| Secondary | Incidence and Titer of Anti Drug Antibody (ADA) against SYS6043, and Incidence of Neutralizing Antibody (NAb), if applicable | Up to approximately 5 years | 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. |
| Secondary | 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) | Up to approximately 5 years | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07879911
GET https://conductscience.org/api/trials/v1/NCT07879911/registered