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RecruitingPhase 2

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses blood tests to look for tiny amounts of cancer DNA after surgery, before cancer can be seen on scans. It is for adults with stage II or III triple-negative breast cancer who still had cancer left at surgery after treatment. The study also tests the safety and possible benefits of an experimental drug, Dato-DXd, when cancer DNA is found but scans do not show cancer returning.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Sign a consent form and give permission to share personal health information.
  • Be willing and able to follow study steps.
  • Have triple-negative breast cancer confirmed by a tissue test that meets the study’s lab rules.
  • Have stage II or III breast cancer treated with medicines before surgery, with cancer left at surgery rated RCB II or III (a measure of how much cancer remains).
  • Have no signs of cancer spread to distant parts of the body on starting scans, as directed by your doctor.
  • Have stored cancer tissue from diagnosis or surgery available.

Who can't join

  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NC