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

Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Create a living biobank of PDOs from Stage I-III lung cancer patients.NCT03655015Josephine Taverna, MD

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoA Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoThis is a Phase 3 open-label, active-control, 2:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as ‘the investigational arm’) vs pembrolizumab alone (referred to as ‘the control arm’) in immune checkpoint inhibitor (ICI) naïve subjects with first line unresectable recurrent and/or metastatic (R/M) HPV16-positive HNSCC with a CPS ≥ 1.NCT06790966Devi Meyyappan MD