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
- 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
- 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
Arm | Description | Assigned Intervention |
---|---|---|
Participants with High Risk Early Breast Cancer | Participants with High Risk Early Breast Cancer |
|
Recruiting Locations
Anchorage 5879400, Alaska 5879092 99508
Theodore Kim
Palo Alto 5380748, California 5332921 94304
Irene Wapnir
Vallejo 5405380, California 5332921 94589
Samantha Seaward
Altamonte Springs 4145941, Florida 4155751 32701
Wassim Mchayleh
Miami Beach 4164143, Florida 4155751 33140
Oleg Gligich
Plantation 4168782, Florida 4155751 33324
Lauren Carcas
Tampa 4174757, Florida 4155751 33607
Robert Gabordi
Chicago 4887398, Illinois 4896861 60607
Ruta Rao
Edgewood 4290873, Kentucky 6254925 41017
Daniel Flora
Louisville 4299276, Kentucky 6254925 40202
John Hamm
Louisville 4299276, Kentucky 6254925 40207
Mounika Mandadi
Baltimore 4347778, Maryland 4361885 21204
Robert Donegan
Baltimore 4347778, Maryland 4361885 21215
Qiwei Gai
Baltimore 4347778, Maryland 4361885 21237
Shweta Kurian
Bethesda 4348599, Maryland 4361885 20818
Victor Priego
Glen Burnie 4356188, Maryland 4361885 21061
Aaron Iddings
Silver Spring 4369596, Maryland 4361885 20910
Cheryl Aylesworth
Towson 4371582, Maryland 4361885 21204
Ethan Rogers
Burlington 4931737, Massachusetts 6254926 01805
Ragisha Gopalakrishnan
Saint Louis Park 5045021, Minnesota 5037779 55426
Yan Ji
New Brunswick 5101717, New Jersey 5101760 08901
Mridula George
Stony Brook 5139865, New York 5128638 11794
Alison Stopeck
Charlotte 4460243, North Carolina 4482348 28204
Arielle Heeke
Pinehurst 4485272, North Carolina 4482348 28374
Charles Kuzma
Rocky Mount 4488762, North Carolina 4482348 27804
Elie Choufani
Canton 5149222, Ohio 5165418 44710
Sunitha Vemulapalli
Cleveland 5150529, Ohio 5165418 44195
Shimoli Barot
Harrisburg 5192726, Pennsylvania 6254927 17111
Kumudini Rao
Hershey 5193342, Pennsylvania 6254927 17033
Cristina Truica
Pittsburgh 5206379, Pennsylvania 6254927 15213
Julia Foldi
Providence 5224151, Rhode Island 5224323 02905
William Sikov
Sioux Falls 5231851, South Dakota 5769223 57105
Jason Jones
Kingsport 4634662, Tennessee 4662168 37660
Asheesh Shipstone
Houston 4699066, Texas 4736286 77030
Vincente Valero
Lubbock 5525577, Texas 4736286 79410
Ibrahim Shalaby
Midlothian 4772943, Virginia 6254928 23114
William Irvin
Richmond 4781708, Virginia 6254928 23298
Elizabeth Barrows
Morgantown 4815352, West Virginia 4826850 26505
Sobha Kurian
Wauwatosa 5278159, Wisconsin 5279468 53226
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 Management1-800-270-3165
industry.trials@nsabp.org