Trial · NCT07879911
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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). |
| Secondary | 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). | 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 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） |
| Other | Correlation Between Efficacy and Expression Levels of Biomarkers Including B7 H3 | Up to approximately 5 years | Exploratory analysis will be performed to evaluate the correlation between tumor biomarker expression levels including B7 H3 and anti tumor efficacy endpoints |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07879911/registered