Primary, secondary and exploratory endpoints
tumor
TUMOR
The primary objective of stage 1 of the BR.36 trial was to validate the concordance of ctDNA molecular response with radiographic RECIST version 1.1 response, ascertain its definition and identify the optimal timepoint for ctDNA molecular response. Secondary objectives included the evaluation of time to ctDNA molecular response, the correlation of ctDNA molecular response with PFS and OS and exploration of the degree of ctDNA reduction with clinical outcomes. The time to ctDNA molecular response was defined similarly based on changes in ctDNA levels, as described below. Tertiary objectives included the collection of archival tumor tissue samples and additional longitudinal plasma samples for future translational studies.