SURMOUNT (Surveillance Markers of Utility for Recurrence after Neoadjuvant Therapy for Breast Cancer) is a nested multi-center, prospective cohort study within the I-SPY2 Trial for women undergoing neoadjuvant chemotherapy for primary breast cancer, who are also undergoing definitive surgical resection and have clinical or radiographic evidence of residual tumor at the completion of chemotherapy.
To determine the frequency, molecular features and prognostic significance of bone marrow and circulating tumor biomarkers in participants with clinical or radiologic residual disease at the completion of neoadjuvant chemotherapy in the I-SPY 2 TRIAL.
Eligible participants drawn from the population of I-SPY 2 TRIAL participants with breast cancer undergoing neoadjuvant chemotherapy at study sites who meet the following eligibility criteria:
The target number of study participants is 250.
Participants will be on the study for 10 years or until recurrence, whichever comes first.The study enrollment is planned for three years
Clinical sites participating in I-SPY2
Aim 1: Estimate and compare the CTC and DTC detection rates by RCB score, tumor subtype and pCR status. Exploratory logistic regression modeling will be performed to determine what additional factors may predict DTC/CTC/CTM detection.
Aim 2: Characterize the molecular and genetic features of DTCs, CTCs, CTMs and compare to the residual and primary tumor. We will estimate correlation coefficients for various features between cells of different types (e.g., DTCs and primary tumor) within the same participant.
Aim 3: Estimate 3-year relapse-free survival in participants with and without detection of DTCs/CTCs at surgery. We will also explore Cox regression models using DTC/CTC detection as a predictor, first in a univariate model and then in multivariate models that include other known prognostic factors. We recognize that power is limited in this cohort to detect anything but quite large effects; these analyses are thus considered exploratory and will provide important preliminary estimates for future study design and hypothesis generation.
clinicaltrials.gov ref: NCT02830282