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Recruiting NCT06401421

EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ctDNA MRD test.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease

Overview

The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.

Interventions

  • Diagnostic test ctDNA MRD test
    Blood and tissue samples will be collected for the ctDNA MRD test

Primary outcome measures

  • Core biopsy tissue evaluability rate [Time frame: 3 years]
  • Distant Recurrence Free Interval (dRFI) [Time frame: 6 years]
Secondary outcome measures (9)
  • Prevalence of tumor mutations and germline variants [Time frame: 6 years]
  • Sensitivity/Specificity [Time frame: 6 years]
  • Prevalence of test positivity [Time frame: 6 years]
  • Pathologic complete response (pCR) status [Time frame: 6 years]
  • Recurrence-free interval (RFI) [Time frame: 6 years]
  • Invasive breast cancer-free survival (IBCFS) [Time frame: 6 years]
  • Event-free survival (EFS) [Time frame: 6 years]
  • Overall survival (OS) [Time frame: 6 years]
  • Lead Time [Time frame: 6 years]

Eligibility criteria

Inclusion criteria

  • The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
  • The participant must be ≥ 18 years of age.
  • ECOG performance status 0 or 1.
  • Histologically confirmed invasive carcinoma of the breast.
  • Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
  • Tumor size ≥ 2.1 cm in greatest diameter.
  • Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
  • Clinically node positive or if node negative, any one of the following:
  • TNBC or HER2+ subtype
  • HR+/HER2-negative with at least one of the following:

i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of > 25, MammaPrint® High, etc.)

  • Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
  • Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.

Exclusion criteria

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Initiated neoadjuvant therapy for current breast cancer diagnosis.
  • Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
  • Completed all therapy (including endocrine therapy) <5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
  • Completed all therapy for any previous hematologic malignancy < 5 years ago.
  • Multicentric or contralateral invasive breast cancers.
  • Known pregnancy at time of enrollment.
  • Prior solid organ transplant.
  • Prior allogeneic hematopoietic stem cell transplant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 53 centers
  • Katmai Oncology Group - Anchorage — Anchorage
  • Stanford Cancer Institute — Palo Alto
  • Harbor-UCLA Medical Center - Hematology / Oncology — Torrance
  • Kaiser Permanente Medical Center — Vallejo
  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora
  • AdventHealth East Altamonte Oncology and Hematology — Altamonte Springs
  • Mount Sinai Medical - Comprehensive Cancer Center — Miami Beach
  • Baptist Cancer Care - Plantation — Plantation
  • … and 45 more centers
Canada · 5 centers
  • Maisonneuve-Rosemont Hospital (HMR) — Montreal
  • Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal
  • Jewish General Hospital — Montreal
  • McGill University Health - Glen Site — Montreal
  • Hôpital du Saint-Sacrement — Québec

Identifiers

NCT: NCT06401421 · 2023-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗