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PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

This study is for people with Stage II/III triple-negative breast cancer (TNBC) who still have some cancer remaining after initial treatment and surgery. It's testing a drug called Datopotamab deruxtecan (Dato-DXd), given intravenously (into a vein) for eight cycles. Researchers are also using a blood test called circulating tumor DNA (ctDNA) testing to look for tiny pieces of cancer DNA in the bloodstream. The main goal is to see how many people with TNBC have molecular residual disease (MRD), meaning ctDNA is found but there's no visible cancer on scans, up to three years after joining the study. This helps understand if ctDNA can detect cancer recurrence early. The study plans to enroll 78 participants.

Study design
This is a Phase II, single-arm study, meaning all participants receive the same treatment. It will involve about 78 people with Stage II/III triple-negative breast cancer.
What's involved
You would receive Datopotamab deruxtecan (Dato-DXd) intravenously for eight cycles. You would also have circulating tumor DNA (ctDNA) testing, which is a blood test.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for up to three years after they register for the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07069595

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~78 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Datopotamab deruxtecanCirculating tumor DNA (ctDNA) testing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)
Measured over Up to 3 years after registration

Conditions

Breast Cancer
Residual Disease
Triple Negative Breast Cancer (TNBC)
Stage II/III

Explore related trials

Triple-negative breast cancerPGR Gene

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Yara Abdou, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Taylor Pierce
[email protected]
(919) 445-4827
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • 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.