Trial · NCT06963905
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations | Three weeks post-Cycle 1 Day 1 (each cycle is 21 days) | The primary outcome measure is the incidence of dose-limiting toxicities (DLTs) observed three weeks after the first cycle of treatment with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination in patients with advanced triple-negative breast cancer in the second-line setting. The assessment will include the frequency and severity of DLTs to evaluate the safety and tolerability of the treatment regimens. |
| Secondary | Time to response in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | Time to Response is defined as the time from the initiation of treatment to the first documentation of a complete response or partial response in patients with advanced TNBC in the second-line setting. This outcome measure will assess the efficacy of sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC, by measuring how quickly patients respond to the therapy.. |
| Secondary | Overall response rate in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Overall Response Rate is defined as the proportion of patients with advanced triple-negative breast cancer in the second-line setting who achieve either a complete response or partial response according to the RECIST version 1.1. The ORR will be assessed in patients receiving sacituzumab govitecan combined with nivolumab, or sacituzumab govitecan combined with nivolumab and relatlimab fixed-dose combination (FDC). This outcome measure aims to evaluate the preliminary efficacy of the treatment regimens. |
| Secondary | Duration of response in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Duration of Response is defined as the time from the first documentation of a complete response or partial response until the time of disease progression or death from any cause, whichever occurs first. This measure will be evaluated in patients with advanced TNBC in the second-line setting who respond to treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The objective is to determine the sustainability of the responses induced by the treatment combinations. |
| Secondary | Clinical benefit rate in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Clinical Benefit Rate is defined as the proportion of patients who achieve a complete response, partial response, or stable disease for at least 6 months, according to RECIST version 1.1. This measure will be assessed in patients with advanced TNBC in the second-line setting undergoing treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The CBR will help determine the overall efficacy and potential benefit of the treatment regimens. |
| Secondary | Progression free survival in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | Progression-Free Survival is defined as the time from the start of treatment to the occurrence of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to the RECIST version 1.1. This outcome measure will evaluate the preliminary efficacy of the treatment regimens involving sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination (FDC) in patients with advanced triple-negative breast cancer (TNBC) in the second-line setting. The intent is to determine how effectively these treatment combinations can delay disease progression and extend the time patients remain progression-free. |
| Secondary | Incidence of adverse events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The incidence of adverse events will be assessed in patients with advanced triple-negative breast cancer in the second-line setting receiving treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab fixed-dose combination (FDC). Adverse events will be recorded and graded according to NCI CTCAE version 5.0. |
| Secondary | Frequency of serious adverse events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The frequency of serious adverse events will be monitored and documented in patients treated with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC. SAEs will be classified and graded according to the NCI CTCAE version 5.0 criteria. |
| Secondary | Incidence of Treatment-Emergent Adverse Events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | Treatment-emergent adverse events will be defined and assessed as any adverse events that arise following the initiation of treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. TEAEs will be graded according to the NCI CTCAE version 5.0 criteria. |
| Secondary | Incidence of Adverse Events of Special Interest in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The incidence of adverse events of special interest will be recorded and evaluated in patients receiving treatment with sacituzumab govitecan combinations. AESIs will include specific adverse events deemed critical based on the known safety profile of the drugs, and will be graded according to the NCI CTCAE version 5.0 criteria. |
| Secondary | Incidence of Immune-Mediated Adverse Events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The occurrence of immune-mediated adverse events will be monitored in patients treated with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC. imAEs will be assessed and graded according to NCI CTCAE version 5.0 criteria to describe the immune-related safety profile of the treatment regimens. |
| Secondary | Rate of Treatment Discontinuation Due to Adverse Events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The rate at which patients discontinue treatment due to adverse events will be assessed. This measure will monitor the proportion of patients with advanced TNBC in the second-line setting who cease treatment with sacituzumab govitecan combinations due to AEs. AEs leading to discontinuation will be documented and graded according to NCI CTCAE version 5.0 criteria. |
| Secondary | Changes in ECOG Performance Status in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The changes in Eastern Cooperative Oncology Group (ECOG) Performance Status will be evaluated at baseline and periodically during treatment to assess the impact of sacituzumab govitecan combinations on patients' functional status. The ECOG Performance Status scale will be utilized to categorize patient performance levels. |
| Secondary | Electrocardiogram abnormalities in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle | Electrocardiogram (ECG) assessments will be conducted to monitor for any treatment-related cardiac abnormalities in patients receiving sacituzumab govitecan combinations. Any significant ECG changes and their clinical relevance will be documented. |
| Secondary | Echocardiogram findings in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle | Echocardiogram (ECHO) assessments will be performed to evaluate cardiac function and detect any cardiotoxicity associated with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. ECHO findings will be analyzed for any significant changes from baseline. |
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.
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