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NCT Number: NCT07069595

PREDICT-RD: 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Residual Disease Skin Diseases Skin and Connective Tissue Diseases Stage II/III Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • Participants are pregnant or breastfeeding.

Treatment and study plan

Datopotamab deruxtecan

Drug

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

Other names: Dato-DXd

Circulating tumor DNA (ctDNA) testing

Diagnostic 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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Duration of Circulating tumor DNA (ctDNA) clearance

    Time frame: 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.

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

    Time frame: 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.

  4. Toxicity of Dato-DXd

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Taylor Pierce

CONTACT

[email protected]

(919) 445-4827

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • AstraZeneca
  • Translational Breast Cancer Research Consortium

Registry information

Official study title

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

Acronym: PREDICT-RD

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jul 16, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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