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.
Analyses will be done across the 3 subtypes in Part 1 and per breast cancer subtype in tissue-evaluable participants in Part 2. For the purposes of this study, subtypes will be defined as follows: Triple Negative Breast Cancer (TNBC), Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-), or HER2+ (inclusive of HR- and HR+), with hormone receptor status and HER2 status defined by current ASCO/CAP guidelines.
Part 1:
To establish the rate of evaluable tissue submissions, defined as the proportion of participants for whom available material from their FFPE diagnostic breast biopsy is sufficient for creation of a participant-specific bespoke ctDNA assay. Feasibility for completing Part 2 will be defined by receipt of evaluable FFPE tissue from diagnostic biopsies in > 60% of participants.
Part 2:
The Primary Objectives for Part 2 will be performed sequentially as listed below:
1. To validate the association of serially measured ctDNA status, starting at the first blood draw following completion of cytotoxic adjuvant therapy for those receiving adjuvant cytotoxic therapy, and at the post-surgery blood draw for those not receiving cytotoxic adjuvant therapy, with distant recurrence-free interval (dRFI).
2. To validate the association of ctDNA positivity detected at the first blood draw following completion of cytotoxic adjuvant therapy for those receiving adjuvant cytotoxic therapy, and at the post-surgery blood draw for those not receiving adjuvant cytotoxic therapy, with dRFI.
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.