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

Purpose

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.

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants with High Risk Early Breast Cancer Participants with High Risk Early Breast Cancer
  • Diagnostic Test: ctDNA MRD test
    Blood and tissue samples will be collected for the ctDNA MRD test
    Other names:
    • Oncodetect™

Recruiting Locations

Katmai Oncology Group - Anchorage
Anchorage 5879400, Alaska 5879092 99508
Contact:
Theodore Kim

Stanford Cancer Institute
Palo Alto 5380748, California 5332921 94304
Contact:
Irene Wapnir

Kaiser Permanente Medical Center
Vallejo 5405380, California 5332921 94589
Contact:
Samantha Seaward

AdventHealth East Altamonte Oncology and Hematology
Altamonte Springs 4145941, Florida 4155751 32701
Contact:
Wassim Mchayleh

Mount Sinai Medical - Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140
Contact:
Oleg Gligich

Baptist Cancer Care - Plantation
Plantation 4168782, Florida 4155751 33324
Contact:
Lauren Carcas

St. Joseph's Women's Hospital
Tampa 4174757, Florida 4155751 33607
Contact:
Robert Gabordi

Rush Cancer Center
Chicago 4887398, Illinois 4896861 60607
Contact:
Ruta Rao

St. Elizabeth Edgewood Hospital
Edgewood 4290873, Kentucky 6254925 41017
Contact:
Daniel Flora

Norton Cancer Institute - Downtown
Louisville 4299276, Kentucky 6254925 40202
Contact:
John Hamm

Baptist Health Louisville
Louisville 4299276, Kentucky 6254925 40207
Contact:
Mounika Mandadi

Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204
Contact:
Robert Donegan

Sinai Hospital of Baltimore
Baltimore 4347778, Maryland 4361885 21215
Contact:
Qiwei Gai

MedStar Georgetown Cancer Institute
Baltimore 4347778, Maryland 4361885 21237
Contact:
Shweta Kurian

The Center for Cancer and Blood Disorders - Bethesda
Bethesda 4348599, Maryland 4361885 20818
Contact:
Victor Priego

Tate Cancer Center at UM Baltimore Washington
Glen Burnie 4356188, Maryland 4361885 21061
Contact:
Aaron Iddings

Holy Cross Hospital - Silver Spring
Silver Spring 4369596, Maryland 4361885 20910
Contact:
Cheryl Aylesworth

University of Maryland St. Joseph Medical Center
Towson 4371582, Maryland 4361885 21204
Contact:
Ethan Rogers

Lahey Hospital & Medical Center
Burlington 4931737, Massachusetts 6254926 01805
Contact:
Ragisha Gopalakrishnan

Metro Minnesota Community Oncology Consortium (MMCORC)
Saint Louis Park 5045021, Minnesota 5037779 55426
Contact:
Yan Ji

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Mridula George

Stony Brook Medicine
Stony Brook 5139865, New York 5128638 11794
Contact:
Alison Stopeck

Atrium Health Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Arielle Heeke

FirstHealth Outpatient Cancer Center
Pinehurst 4485272, North Carolina 4482348 28374
Contact:
Charles Kuzma

UNC Cancer Care at Nash
Rocky Mount 4488762, North Carolina 4482348 27804
Contact:
Elie Choufani

Aultman Timken Family Cancer Center
Canton 5149222, Ohio 5165418 44710
Contact:
Sunitha Vemulapalli

Cleveland Clinic Main Campus
Cleveland 5150529, Ohio 5165418 44195
Contact:
Shimoli Barot

Penn State Health Medical Group - Andrews Patel
Harrisburg 5192726, Pennsylvania 6254927 17111
Contact:
Kumudini Rao

Penn State Cancer Institute
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Cristina Truica

UPMC Magee - Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Julia Foldi

Women & Infants Hospital
Providence 5224151, Rhode Island 5224323 02905
Contact:
William Sikov

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Jason Jones

Ballad Health Cancer Center
Kingsport 4634662, Tennessee 4662168 37660
Contact:
Asheesh Shipstone

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Vincente Valero

Joe Arrington Cancer Research & Treatment Center
Lubbock 5525577, Texas 4736286 79410
Contact:
Ibrahim Shalaby

Bon Secours Cancer Institute at St. Francis
Midlothian 4772943, Virginia 6254928 23114
Contact:
William Irvin

VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Elizabeth Barrows

WVU Cancer Institute
Morgantown 4815352, West Virginia 4826850 26505
Contact:
Sobha Kurian

Aurora Cancer Care - Wauwatosa
Wauwatosa 5278159, Wisconsin 5279468 53226
Contact:
Peter Polewski

More Details

NCT ID
NCT06401421
Status
Recruiting
Sponsor
Exact Sciences Corporation

Study Contact

NSABP Department of Site and Study Management Department of Site and Study Management
1-800-270-3165
industry.trials@nsabp.org