Table 1.
Recently completed and ongoing clinical trials using ctDNA detection for breast cancer mentioned in the main text.
| Study | Trial Number | Purpose |
|---|---|---|
| Early disease detection | ||
| ASCEND | NCT04213326 | To develop and validate the classification algorithm used by the CancerSEEK cancer screening test by collecting clinically annotated peripheral blood specimens from subjects with cancer and no known cancer |
| SUMMIT | NCT03934866 | To evaluate the performance of cfNA signals measured using high-intensity sequencing (ultra-deep and ultra-broad) for the detection of invasive cancer and identification of tissue of cancer origin using a GRAIL blood test |
| STRIVE | NCT03085888 | To evaluate the performance of the pre-specified GRAIL test to detect invasive cancers (including haematological malignancies) and to refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers |
| PATHFINDER | NCT04241796 | To determine the time and level of testing required for diagnostic resolution following a signal detected in a multi-cancer early detection test with stratification of elevated risk groups on the basis of history of smoking, documented genetic cancer predisposition, or personal history of invasive or haematological malignancy |
| Prognosis: early indications of outcome and recurrence | ||
| c-TRAK-TN | NCT03145961 | To assess whether ctDNA screening can be used to detect residual disease following patients standard primary treatment for triple negative breast cancer |
| Opportunities for treatment of metastatic disease | ||
| plasmaMATCH | NCT03182634 | To assess whether ctDNA screening can be used to detect patient subgroups who will be sensitive to targeted therapies and determine the safety and activity of the targeted treatments |
| EMERALD | NCT03778931 | ctDNA utilised for stratification in Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) |
| PADA-1 | NCT03079011 | To evaluate, at the onset of ESR1 mutations in circulating tumour DNA, the efficacy of a change of the hormone therapy |
| INTERACT | NCT04256941 | To assess circulating tumour deoxyribonucleic acid (ctDNA) ESR1 mutant allele fraction (MAF) and kinetics with fulvestrant compared with AI and to correlate ctDNA with cancer antigens (CA) 15-3 tumour marker changes |
| BYL719 plus letrozole or exemestane for patients with HR-positive locally advanced unresectable or MBC | NCT01870505 | ctDNA utilised for descriptive purposes |