Clinical trial NCT06401421: EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
ctDNA
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: NSABP Foundation Inc
First posted: 2024-05-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who will undergo neoadjuvant treatment for high-risk, early breast cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Core biopsy tissue evaluability rate
timeFrame: 3 years
measure: Distant Recurrence Free Interval (dRFI)
timeFrame: 6 years
Secondary outcomes:
measure: Prevalence of tumor mutations and germline variants
timeFrame: 6 years
measure: Sensitivity/Specificity
timeFrame: 6 years
measure: Prevalence of test positivity
timeFrame: 6 years
measure: Pathologic complete response (pCR) status
timeFrame: 6 years
measure: Recurrence-free interval (RFI)
timeFrame: 6 years
measure: Invasive breast cancer-free survival (IBCFS)
timeFrame: 6 years
measure: Event-free survival (EFS)
timeFrame: 6 years
measure: Overall survival (OS)
timeFrame: 6 years
measure: Lead Time
timeFrame: 6 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Katmai Oncology Group - Anchorage
state: Alaska
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Altamonte Springs
country: United States
facility: AdventHealth East Altamonte Oncology and Hematology
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical - Comprehensive Cancer Center
state: Florida
city: Plantation
country: United States
facility: Baptist Cancer Care - Plantation
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Women's Hospital
state: Florida
city: Chicago
country: United States
facility: Rush Cancer Center
state: Illinois
city: Edgewood
country: United States
facility: St. Elizabeth Edgewood Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - Downtown
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: MedStar Georgetown Cancer Institute
state: Maryland
city: Bethesda
country: United States
facility: The Center for Cancer and Blood Disorders - Bethesda
state: Maryland
city: Glen Burnie
country: United States
facility: Tate Cancer Center at UM Baltimore Washington
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital - Silver Spring
state: Maryland
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Consortium (MMCORC)
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer Institute
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Rocky Mount
country: United States
facility: UNC Cancer Care at Nash
state: North Carolina
city: Canton
country: United States
facility: Aultman Timken Family Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Harrisburg
country: United States
facility: Penn State Health Medical Group - Andrews Patel
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee - Womens Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Kingsport
country: United States
facility: Ballad Health Cancer Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research & Treatment Center
state: Texas
city: Midlothian
country: United States
facility: Bon Secours Cancer Institute at St. Francis
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Comprehensive Cancer Center
state: Virginia
city: Morgantown
country: United States
facility: WVU Cancer Institute
state: West Virginia
city: Wauwatosa
country: United States
facility: Aurora Cancer Care - Wauwatosa
state: Wisconsin
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital (HMR)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health - Glen Site
state: Quebec
city: Québec City
country: Canada
facility: Hôpital du Saint-Sacrement
state: Quebec
Study officials:
References: