S2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreS2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreThis clinical trial aims to validate the results observed in I-SPY2 and will test if adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in early-stage HRpositive MP2 cancers.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

Phase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyPhase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyThis is a single institution, non-randomized, phase 1 with a dose expansion clinical trial investigating the addition of a novel agent, Avasopasem (GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerA Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerThis is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.ClinicalTrials.gov registration not requiredAhmed Mansour Elkenany MD

MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer This is a prospective, observational study designed to evaluate the clinical validity of Myriad Genetics’ MRD test in patients diagnosed with breast cancer. It is expected that enrollment will be split between the different breast cancer subtypes defined by immunohistochemistry (HR+/HER2-, HER2+ (HR+ and HR-), TNBC) and according to BINV-A of National Comprehensive Cancer Network guidelines with ER+ status used here as >10% of nuclei staining.ClinicalTrials.gov registration not requiredMarcela Mazo Canola MD