Trial · NCT07903181
Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast
NCT07903181, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast. Trials, record NCT07903181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast
- NCT number
- NCT07903181
- Status
- Not yet recruiting
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Conditions
- Malignant Phyllodes Tumor of the Breast
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival According to Early ctDNA Status Transition Patterns | From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA at pretreatment baseline and before Cycle 3. Cycle length varies by regimen (usually 28 days; sometimes 21 days or other durations). | Circulating tumor DNA (ctDNA) detection status at pretreatment baseline (T0) and before cycle 3 (T2) defines four groups: negative at both visits, negative-to-positive, positive-to-negative, and positive at both visits. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause. Censoring follows the study protocol. Comparisons include participants with valid paired results who remain event-free at T2. T2 status is applied only after collection of the T2 sample, with appropriate risk-set handling to avoid immortal time bias. PFS will be summarized across the four groups; exploratory Cox regression will estimate hazard ratios and 95% confidence intervals if the number of events permits. Otherwise, descriptive survival results will be reported. |
| Secondary | Progression-Free Survival According to Baseline ctDNA Detection Status | From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA status measured before the first treatment dose. | At pretreatment baseline (T0), circulating tumor DNA (ctDNA) detection status is classified as positive or negative according to prespecified assay criteria. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the study protocol. PFS will be summarized by baseline ctDNA status. If the number of events permits, Cox regression will estimate the hazard ratio for ctDNA-positive versus ctDNA-negative participants with a 95% confidence interval. |
| Secondary | Progression-Free Survival According to Baseline ctDNA Concentration | From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA concentration measured before the first treatment dose. | Circulating tumor DNA (ctDNA) concentration is measured before treatment initiation (T0) in haploid genome equivalents per milliliter (hGE/mL). Baseline concentration is evaluated as a continuous predictor without a prespecified high/low cutoff. Reliably quantifiable positive concentrations will be log2-transformed for exploratory analysis. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. A Cox model will estimate the hazard ratio and 95% confidence interval if data permit. Nondetectable or nonquantifiable values will be handled according to prespecified rules. |
| Secondary | Progression-Free Survival According to ctDNA Status Transitions Before Cycle 2 | From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations). | Circulating tumor DNA (ctDNA) detection status at pretreatment baseline (T0) and before cycle 2 (T1) defines four groups: negative at both visits, negative-to-positive, positive-to-negative, and positive at both visits. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. Comparisons include participants with valid T0 and T1 results who remain event-free at T1. T1 status enters the analysis only after T1 sampling, with appropriate risk-set handling. PFS will be summarized by group; exploratory Cox regression will be performed if event counts permit. |
| Secondary | Progression-Free Survival According to the ctDNA Concentration Ratio at T1 Versus Baseline | From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations). | Circulating tumor DNA (ctDNA) concentration is measured in haploid genome equivalents per milliliter (hGE/mL) at pretreatment baseline (T0) and before cycle 2 (T1). For participants with reliably quantifiable concentrations at both visits and T0 \> 0, the T1/T0 ratio is calculated as T1 concentration divided by T0 concentration; the ratio is unitless. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. The ratio will be evaluated as a continuous predictor in exploratory Cox regression if data permit, using only risk time after T1 sampling. Invalid or nonquantifiable ratios will not be assigned arbitrary values. |
| Secondary | Progression-Free Survival According to the ctDNA Concentration Ratio at T2 Versus Baseline | From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 3. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations). | Circulating tumor DNA (ctDNA) concentration is measured in haploid genome equivalents per milliliter (hGE/mL) at pretreatment baseline (T0) and before cycle 3 (T2). For participants with reliably quantifiable concentrations at both visits and T0 \> 0, the T2/T0 ratio is calculated as T2 concentration divided by T0 concentration; the ratio is unitless. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. The ratio will be evaluated as a continuous predictor in exploratory Cox regression if data permit, using only risk time after T2 sampling. Invalid or nonquantifiable ratios will not be assigned arbitrary values. |
| Secondary | Progression-Free Survival According to Time-Updated ctDNA Detection Status at Subsequent Imaging Visits | From treatment-line initiation to imaging-confirmed progression, death, or censoring (up to 24 months); ctDNA at routine CT/MRI visits following pre-cycle 3 sampling. Cycle length varies by regimen (usually 28 days; may be 21 days or other lengths). | Circulating tumor DNA (ctDNA) detection status (positive or negative) is assessed at routine CT/MRI imaging visits after T2 (T3 and later) during the current systemic treatment line. Progression-free survival (PFS), measured in months, is the time from treatment-line initiation to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. If sufficient data are available, a Cox model with ctDNA status as a time-varying covariate will estimate the hazard ratio for positive versus negative status and its 95% confidence interval. Status is updated at the actual sampling date; only previously collected samples are used to evaluate subsequent risk. If modeling is not feasible, findings will be descriptive. |
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.
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT07903181
GET https://conductscience.org/api/trials/v1/NCT07903181/registered