EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk A Study of imlunestrant vs physician’s choice endocrine therapy as adjuvant treatment after 2 to 5 years of standard adjuvant endocrine therapy for patients with ER+, HER2- early breast cancer with an increased risk of recurrenceClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)This is a Phase 3, global, multicenter, randomized, open-label study.ClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

A Phase 1a/1b Study of the PI3a:RSS Breaker BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial) A Phase 1a/1b Study of the PI3a:RSS Breaker BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial) First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with trastuzumab in patients with advanced solid tumors.ClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast CancerVIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast CancerThis is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.NCT06757634Virginia Kaklamani, MD, DSc

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who ReceivA Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who ReceivThis clinical study will evaluate MK-2870 plus pembrolizumab versus TPC for the treatment of participants with TNBC who did not achieve pCR at surgery following neoadjuvant therapy with pembrolizumab plus chemotherapy.NCT06393374Virginia Kaklamani, MD, DSc

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