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Breast CancerPhase 2PREDICT-RDNCT07069595

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

A Phase 2 study testing Datopotamab deruxtecan and Circulating tumor DNA (ctDNA) testing in people with Breast Cancer and Residual Disease, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Datopotamab deruxtecan and Circulating tumor DNA (ctDNA) testing
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
26 Feb 2026to 1 Nov 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.
  • Participant is willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.
  • Histological confirmation of TNBC defined by ER/PR <10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.
  • Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery.
  • Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.
  • The participant must have archival diagnostic tissue and/or surgical resection tissue Available.
  • Participants are willing and able to comply with study procedures based on the judgment of the investigator.

Who cannot join

  • Participants are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taylor Pierce contact

(919) 445-4827

Taylor_Pierce@med.unc.edu

United States1 site, 1 recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

    Ana Gallegos, 919-445-4827, ana_gallegos@med.unc.edu

    Taylor Pierce, (919) 445-4827, tepierce@email.unc.edu

    Recruiting

Other trials in United States

About this study

Official title: PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.

The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.

Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

Read the detailed description

Despite treatment advances, patients with II/III triple negative breast cancer (TNBC) residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. Furthermore, early detection of relapse risk, when the residual disease burden is micrometastatic (defined here as undetectable by standard cross-sectional imaging), provides a chance for disease eradication whereas macrometastatic disease (i.e., detectable on standard cross-sectional imaging) is generally considered to be non-curable.

There are no standard of care (SOC) surveillance strategies for early detection of micrometastatic disease in high-risk TNBC beyond clinical monitoring. Detecting molecular residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective systemic therapy.

Being tested
Datopotamab deruxtecan, Circulating tumor DNA (ctDNA) testing
Keywords
circulating tumor DNA (ctDNA), surveillance, Dato-DXd
Medical subject headings
Breast Neoplasms, Neoplasm, Residual, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datopotamab deruxtecanDrug

    Also called Dato-DXd

    Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.

  • Circulating tumor DNA (ctDNA) testingDiagnostic test

    Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy.

Study groups in NCT07069595
Study groupRoleWhat they receive
Patients with higher residual cancer burdenExperimentalParticipants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.
Receives: Drug: Datopotamab deruxtecan; Diagnostic Test: Circulating tumor DNA (ctDNA) testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)

    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.

    Measured: Up to 3 years after registration

Secondary outcomes (8)

  1. The time between Circulating tumor DNA (ctDNA) positivity and clinically proven relapse

    ctDNA levels will be measured every 6 weeks during adjuvant and/or Dato-DXd therapy and every 12 weeks thereafter.

    Measured: Up to 3 years after registration

  2. Duration of Circulating tumor DNA (ctDNA) clearance

    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.

    Measured: Up to 3 years after registration

  3. Circulating tumor DNA (ctDNA) clearance with Dato-DXd

    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.

    Measured: Up to 3 years after registration

  4. Toxicity of Dato-DXd

    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.

    Measured: Up to 3 years after registration

  5. Recurrence Free Survival (RFS) for ctDNA-positive and ctDNA-negative disease.

    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.

    Measured: Up to 3 years after registration

  6. Recurrence Free Survival (RFS) - Dato-DXd

    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.

    Measured: Up to 3 years after registration

  7. Overall Survival (OS) - ctDNA-positive and ctDNA and negative disease.

    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.

    Measured: Up to 3 years after registration

  8. Overall Survival (OS) - for ctDNA-positive and ctDNA-negative disease.

    OS will be measured from the day of the first ctDNA measurement to death from any cause in participants who receive Dato-DXd.

    Measured: Up to 3 years after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start26 Feb 2026
  3. Primary completion1 Nov 2031 (estimated)
  4. Study completion1 Nov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07069595
Sponsor's protocol ID
LCCC2215
Acronym
PREDICT-RD
Status last verified
Apr 2026
First submitted
7 Jul 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Datopotamab deruxtecan and Circulating tumor DNA (ctDNA) testing in people with Breast Cancer and Residual Disease, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taylor Pierce ((919) 445-4827, Taylor_Pierce@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD) (time frame: Up to 3 years after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07069595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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