Trial · NCT05770531
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
NCT05770531, Phase 2, Recruiting, Vanderbilt-Ingram Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy. Trials, record NCT05770531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05770531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
- NCT number
- NCT05770531
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Metastatic HER2-Negative Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
- Interventions
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection, Sacituzumab Govitecan
- First posted
- 2023-03-15
- Last updated
- 2026-06-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to 3 years | The study survival will be estimated using the Kaplan-Meier method with 95% confidence intervals (CIs). The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for PFS with log-rank tests. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age, on the survival data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence intervals will be reported. |
| Secondary | Incidence of adverse events | From initiation of study-indicated treatment until 30 days after final study-indicated treatment or until initiation of another anticancer therapy, whichever occurs first | Adverse events will be graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events version 5.0. Adverse medical events will be tabulated. NCI toxicity grade 3 and grade 4 laboratory abnormalities will be listed. |
| Secondary | Progression free survival 2 | Up to 3 years | The study survival will be estimated using the Kaplan-Meier method with 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for PFS2 with log-rank tests. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age, on the survival data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence intervals will be reported. |
| Secondary | Overall survival (OS) | Up to 3 years | The study survival will be estimated using the Kaplan-Meier method with 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for OS with log-rank tests. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age, on the survival data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence intervals will be reported. |
| Secondary | Response rate (RR) | Up to 3 years | The exact two-sided 95% confidence intervals for the RR will be reported for each arm. The Fisher's exact test will be used to examine the difference of RR between treatment arms. |
Source ClinicalTrials.gov
Outcomes0
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/NCT05770531
GET https://conductscience.org/api/trials/v1/NCT05770531/registered