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

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study 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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Anchorage

Katmai Oncology Group - Anchorage, Anchorage, Alaska, United States, 99508

Vallejo

Kaiser Permanente Medical Center, Vallejo, California, United States, 94589

Altamonte Springs

AdventHealth East Altamonte Oncology and Hematology, Altamonte Springs, Florida, United States, 32701

Miami Beach

Mount Sinai Medical - Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Louisville

Norton Cancer Institute - Downtown, Louisville, Kentucky, United States, 40202

Louisville

Baptist Health Louisville, Louisville, Kentucky, United States, 40207

Baltimore

Greater Baltimore Medical Center, Baltimore, Maryland, United States, 21204

Baltimore

MedStar Georgetown Cancer Institute, Baltimore, Maryland, United States, 21237

Bethesda

The Center for Cancer and Blood Disorders - Bethesda, Bethesda, Maryland, United States, 20818

Silver Spring

Holy Cross Hospital - Silver Spring, Silver Spring, Maryland, United States, 20910

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exact Sciences Corporation,

Study Record Dates

2030-04