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

Recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: ctDNA MRD test

• Registration Number: NCT06401421
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-06
• Study Start: 2024-06-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with High Risk Early Breast Cancer	ctDNA MRD test	Participants with High Risk Early Breast Cancer

Primary Outcome Measures

Name	Time	Method
Distant Recurrence Free Interval (dRFI)	6 years
Core biopsy tissue evaluability rate	3 years

Secondary Outcome Measures

Name	Time	Method
Invasive breast cancer-free survival (IBCFS)	6 years
Sensitivity/Specificity	6 years
Prevalence of test positivity	6 years
Recurrence-free interval (RFI)	6 years
Event-free survival (EFS)	6 years
Overall survival (OS)	6 years
Lead Time	6 years
Prevalence of tumor mutations and germline variants	6 years
Pathologic complete response (pCR) status	6 years

Trial Locations

Locations (42)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States

Penn State Health Medical Group - Andrews Patel; 🇺🇸 Harrisburg, Pennsylvania, United States

Penn State Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States

Maisonneuve-Rosemont Hospital (HMR); 🇨🇦 Montréal, Quebec, Canada

Katmai Oncology Group - Anchorage; 🇺🇸 Anchorage, Alaska, United States

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Vallejo, California, United States

AdventHealth East Altamonte Oncology and Hematology; 🇺🇸 Altamonte Springs, Florida, United States

Mount Sinai Medical - Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Baptist Cancer Care - Plantation; 🇺🇸 Plantation, Florida, United States

Rush Cancer Center; 🇺🇸 Chicago, Illinois, United States

St. Elizabeth Edgewood Hospital; 🇺🇸 Edgewood, Kentucky, United States

Norton Cancer Institute - Downtown; 🇺🇸 Louisville, Kentucky, United States

Baptist Health Louisville; 🇺🇸 Louisville, Kentucky, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

MedStar Georgetown Cancer Institute; 🇺🇸 Baltimore, Maryland, United States

The Center for Cancer and Blood Disorders - Bethesda; 🇺🇸 Bethesda, Maryland, United States

Tate Cancer Center at UM Baltimore Washington; 🇺🇸 Glen Burnie, Maryland, United States

Holy Cross Hospital - Silver Spring; 🇺🇸 Silver Spring, Maryland, United States

University of Maryland St. Joseph Medical Center; 🇺🇸 Towson, Maryland, United States

Metro Minnesota Community Oncology Consortium (MMCORC); 🇺🇸 Saint Louis Park, Minnesota, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Stony Brook Medicine; 🇺🇸 Stony Brook, New York, United States

Atrium Health Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

FirstHealth Outpatient Cancer Center; 🇺🇸 Pinehurst, North Carolina, United States

UNC Cancer Care at Nash; 🇺🇸 Rocky Mount, North Carolina, United States

Aultman Timken Family Cancer Center; 🇺🇸 Canton, Ohio, United States

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States

UPMC Magee - Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Women & Infants Hospital; 🇺🇸 Providence, Rhode Island, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Ballad Health Cancer Center; 🇺🇸 Kingsport, Tennessee, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Joe Arrington Cancer Research & Treatment Center; 🇺🇸 Lubbock, Texas, United States

Bon Secours Cancer Institute at St. Francis; 🇺🇸 Midlothian, Virginia, United States

VCU Massey Comprehensive Cancer Center; 🇺🇸 Richmond, Virginia, United States

WVU Cancer Institute; 🇺🇸 Morgantown, West Virginia, United States

Aurora Cancer Care - Wauwatosa; 🇺🇸 Wauwatosa, Wisconsin, United States

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada

McGill University Health - Glen Site; 🇨🇦 Montréal, Quebec, Canada

Hôpital du Saint-Sacrement; 🇨🇦 Québec City, Quebec, Canada