Detection of molecular residual disease in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EXActDNA-003 study aims to enroll participants with high-risk, early breast cancer who are about to start chemotherapy. Participants will provide tissue and blood samples for analysis of circulating tumor DNA (ctDNA) to detect molecular residual disease. The study will follow these participants for up to 5.5 years to assess the effectiveness of ctDNA monitoring in this context. This observational study will help understand the role of ctDNA in managing breast cancer treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Katmai Oncology Group - Anchorage
  Anchorage, Alaska, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting
• Harbor-UCLA Medical Center - Hematology / Oncology
  Torrance, California, United States Recruiting
• Kaiser Permanente Medical Center
  Vallejo, California, United States Recruiting
• UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• AdventHealth East Altamonte Oncology and Hematology
  Altamonte, Florida, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: NSABP Department of Site and Study Management Department of Site and Study Management
• Email: industry.trials@nsabp.org
• Phone: 1-800-270-3165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.