Trial · NCT07069595
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
NCT07069595, Phase 2, Recruiting, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease. Trials, record NCT07069595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07069595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
- NCT number
- NCT07069595
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 78 participants, estimated
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Breast Cancer, Residual Disease, Triple Negative Breast Cancer (TNBC), Stage II/III
- Interventions
- Datopotamab deruxtecan, Circulating tumor DNA (ctDNA) testing
- First posted
- 2025-07-16
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD) | Up to 3 years after registration | The number of participants with triple negative breast cancer (TNBC) with molecular residual disease (MRD) only recurrence, which is defined as ctDNA positivity without radiographically measurable recurrence, during post-surgery surveillance. |
| Secondary | The time between Circulating tumor DNA (ctDNA) positivity and clinically proven relapse | Up to 3 years after registration | ctDNA levels will be measured every 6 weeks during adjuvant and/or Dato-DXd therapy and every 12 weeks thereafter. |
| Secondary | Duration of Circulating tumor DNA (ctDNA) clearance | Up to 3 years after registration | Duration of ctDNA clearance will be defined as the time from the first confirmed clearance (for negative test after positive results) to the date of confirmed positivity. |
| Secondary | Circulating tumor DNA (ctDNA) clearance with Dato-DXd | Up to 3 years after registration | ctDNA clearance in participants who receive Dato-DXd will be defined as the proportion of participants who convert from ctDNA positive to negative after initiation of Dato-DXd. |
| Secondary | Toxicity of Dato-DXd | Up to 3 years after registration | Toxicity of Dato-DXd treatment will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. NCI-CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Secondary | Recurrence Free Survival (RFS) for ctDNA-positive and ctDNA-negative disease. | Up to 3 years after registration | RFS will be measured from the day of the first circulating tumor DNA (ctDNA) measurement to documented recurrence of disease in participants with ctDNA-positive and ctDNA-negative disease. |
| Secondary | Recurrence Free Survival (RFS) - Dato-DXd | Up to 3 years after registration | RFS will be measured from the day of the first circulating tumor DNA (ctDNA) measurement to documented recurrence of disease in participants who receive Dato-DXd. |
| Secondary | Overall Survival (OS) - ctDNA-positive and ctDNA and negative disease. | Up to 3 years after registration | OS will be measured from the day of the first ctDNA measurement to death from any cause in participants with ctDNA-positive and ctDNA-negative disease. |
| Secondary | Overall Survival (OS) - for ctDNA-positive and ctDNA-negative disease. | Up to 3 years after registration | OS will be measured from the day of the first ctDNA measurement to death from any cause in participants who receive Dato-DXd. |
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/NCT07069595
GET https://conductscience.org/api/trials/v1/NCT07069595/registered