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

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 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous This is a Phase 2, randomized, active-controlled, parallel-group, multisite, open-label studyof belzutifan plus fulvestrant versus everolimus plus ETPC (fulvestrant or exemestane) inparticipants with ER+/HER2- unresectable, locally advanced, or mBC.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684 is being developed for treatment of solid tumors. This basket study of MK-5684 isdesigned to assess the safety, tolerability, and preliminary efficacy of MK-5684 in selectedadvanced solid tumor indications.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer.NCT07102381Saba Shaikh, MD