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  • A Phase 1, First-in-Human Study Of MEN2312, A KAT6 Inhibitor, As Monotherapy And In Combination In Participants With Advanced Breast Cancer Rochester, MN This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
  • A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 In Patients With Relapsed Or Refractory Triple Negative Breast Cancer Jacksonville, FL Rochester, MN

    The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced triple negative breast cancer. The main questions the study aims to answer are:

    * What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer.
    * What side effects do participants have when taking CLR 125.

    Participants will:

    * Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks.
    * Visit the clinic once every 3 weeks for checkups and testing.
    * Report any side effects or new medications.

    Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will:

    * Have 4 scans completed over 2 weeks
    * Have blood drawn 6 times over 2 weeks.
  • MC250301, OptiOFS: A Randomized Phase II Trial Of Alternative Site Goserelin Acetate Injection For Ovarian Function Suppression (OFS) In Local And Locally Advanced Premenopausal Breast Cancer Rochester, MN

    The purpose of this study is to determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.
  • TBCRC Evolutionary Clinical Trial For Novel Biomarker-Driven Therapies (EVOLVE-BDT) Rochester, MN This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

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  • A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

    This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the  recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
  • PREDICT-RD: Postoperative Molecular Residual Disease By CtDNA Surveillance In TNBC With Residual Disease Jacksonville, FL Rochester, MN This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.

    The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.

    Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

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