RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-06-07

Study Completion:2030-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06401421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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.

Inclusion Criteria

Exclusion 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:
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.

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.

Contacts and Locations

Study Contact

NSABP Department of Site and Study Management Department of Site and Study Management

CONTACT

1-800-270-3165

industry.trials@nsabp.org

Study Locations (Sites)

Katmai Oncology Group - Anchorage

Anchorage, Alaska, 99508

United States

Kaiser Permanente Medical Center

Vallejo, California, 94589

United States

AdventHealth East Altamonte Oncology and Hematology

Altamonte Springs, Florida, 32701

United States

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202

United States

Baptist Health Louisville

Louisville, Kentucky, 40207

United States

Greater Baltimore Medical Center

Baltimore, Maryland, 21204

United States

MedStar Georgetown Cancer Institute

Baltimore, Maryland, 21237

United States

The Center for Cancer and Blood Disorders - Bethesda

Bethesda, Maryland, 20818

United States

Holy Cross Hospital - Silver Spring

Silver Spring, Maryland, 20910

United States

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204

United States

Metro Minnesota Community Oncology Consortium (MMCORC)

Saint Louis Park, Minnesota, 55426

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

Stony Brook Medicine

Stony Brook, New York, 11794

United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374

United States

UNC Cancer Care at Nash

Rocky Mount, North Carolina, 27804

United States

Aultman Timken Family Cancer Center

Canton, Ohio, 44710

United States

Women & Infants Hospital

Providence, Rhode Island, 02905

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Ballad Health Cancer Center

Kingsport, Tennessee, 37660

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410

United States

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia, 23114

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

United States

WVU Cancer Institute

Morgantown, West Virginia, 26505

United States

Aurora Cancer Care - Wauwatosa

Wauwatosa, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Exact Sciences Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07

Study Completion Date2030-04

Study Record Updates

Study Start Date2024-06-07

Study Completion Date2030-04

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
ctDNA

Additional Relevant MeSH Terms

Breast Cancer