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

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

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 looks at blood tests that find small pieces of tumor DNA, called ctDNA, in people with high-risk, early breast cancer. It is for adults who plan to have chemotherapy before surgery and agree to give blood and tumor tissue samples. Participants will be followed for up to 5.5 years.

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.

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

Eligibility

Who can join

  • You must be age 18 or older. You or your legal representative must give informed consent to join.
  • You must be fully active or able to do light work despite limits on hard physical activity.
  • A tissue test must confirm breast cancer that has grown beyond where it started. The tumor must be at least 2.1 cm across.
  • You must plan to have treatment before surgery that includes chemotherapy to kill cancer cells.
  • You may have one tumor or several tumors, but they must have the same cancer subtype.
  • Cancer must involve nearby lymph nodes, or meet certain risk rules if nodes are not involved: triple-negative or HER2-positive cancer; or hormone receptor-positive, HER2-negative cancer with grade 3 cells, a Ki67 growth score of at least 20%, or a high gene-test risk score, such as Oncotype DX above 25 or MammaPrint High.
  • You must be willing and able to follow study rules, including giving 34 cc (about 2.5 tablespoons) of blood at each research blood draw.
  • Leftover tissue from your breast biopsy or an involved lymph node on the same side must be available to make a personal ctDNA test.

Who can't join

  • Tests or exams clearly show that the cancer has spread to distant parts of the body.
  • You have already started treatment before surgery for your current breast cancer.
  • You have another invasive cancer diagnosed at the same time, except non-melanoma skin cancer.
  • You finished treatment for a past invasive cancer, including breast cancer or a blood cancer, less than 5 years ago. This includes hormone treatment. Non-melanoma skin cancer is an exception; past noninvasive cancer is allowed if fully treated.
  • You have invasive breast cancers in separate areas of the same breast or in the other breast.
  • You are known to be pregnant when you join.
  • You have had a solid organ transplant.
  • You have had a blood-forming stem cell transplant using cells from a donor.

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

Official eligibility criteria

Inclusion Criteria: 1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry. 2. The participant must be ≥ 18 years of age. 3. ECOG performance status 0 or 1. 4. Histologically confirmed invasive carcinoma of the breast. 5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy. 6. Tumor size ≥ 2.1 cm in greatest diameter. 7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype. 8. Clinically node positive or if node negative, any one of the following: 1. TNBC or HER2+ subtype 2. 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.) 9. 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. 10. 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: 1. Definitive clinical or radiologic evidence of metastatic disease. 2. Initiated neoadjuvant therapy for current breast cancer diagnosis. 3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers. 4. 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. 5. Completed all therapy for any previous hematologic malignancy \< 5 years ago. 6. Multicentric or contralateral invasive breast cancers. 7. Known pregnancy at time of enrollment. 8. Prior solid organ transplant. 9. Prior allogeneic hematopoietic stem cell transplant.

Study sites (53)

AK

CA

CO

  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center · Aurora, CO 80045Marie Wood · Study contactMore trials in Aurora

FL

IL

IN

  • Deaconess Chancellor Center for Oncology · Newburgh, IN 47630Samer Schuman · Study contactMore trials in Newburgh

KS

KY

MA

MD

MN

MO

NC

NJ

NY

OH

PA

RI

SC

SD

TN

TX

  • The University of Texas MD Anderson Cancer Center · Houston, TX 77030Vincente Valero · Study contactMore trials in Houston
  • Joe Arrington Cancer Research & Treatment Center · Lubbock, TX 79410Ibrahim Shalaby · Study contactMore trials in Lubbock

VA

WI

WV