Breast Clinical Trials

Breast

22101- 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 of Recurrence – 22101-EMBER-4 – J2J-MC-JZLH-NCT05514054-ELI LILLY

• Phase – III
• Stage(s) – I, II, III
• Line of Therapy – 2+
• Investigational Drug – Imlunestrant (LY3484356)
• Drug Class – SERD
• Mechanism of Action – Antagonistic properties that cause continuous inhibition of ER-dependent gene transcription and cell growth
• Biomarker(s) – ER+, HER2-

22159- A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) (CELC-G-301)

• Phase – III
• Stage(s) – III, IV
• Line of Therapy – 2nd, 3rd
• Investigational Drug – Gedatolisib(PF-05212384)
• Drug Class – PI3K/mTOR Inhibitor
• Mechanism of Action – Binds the different p110 catalytic subunit isoforms of PI3K and the kinase site of mTOR
• Biomarker(s) – HR+, HER2-

23189- Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) (DB-1303-O-3002) – 23189- DYNASTY-Breast02-DB-1303-O-3002- NCT06018337-IQVIA

• Phase – III
• Stage(s) – Advanced or Metastic
• Line of Therapy – 1st, 2nd
• Investigational Drug – DB-1303
• Drug Class – Antibody Drug Conjugate
• Mechanism of Action – Third-generation topoisomerase-1 inhibitor-based
• Biomarker(s) – HER2-low expression

22333- Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer (BRE 381)

• Phase – II
• Stage(s) – Locally advanced/metastatic disease
• Line of Therapy – Must have at least one prior line of anti-HER2 therapy
• Investigational Drug – Tucatinib
• Drug Class – Oral TKI selective for HER2
• Mechanism of Action – Tucatinib is an oral tyrosine kinase inhibitor selective for HER2
• Biomarker(s) – HER2+

23059- A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY (CO44657)

• Phase – III
• Stage(s) – Advanced
• Investigational Drug – Giredestrant (GDC-9545, RO7197597)
• Drug Class – Selective Estrogen Receptor Degrader (SERD)
• Mechanism of Action – Direct binding to estrogen receptor, proteasome-mediated degradation, anti-tumor effect
• Biomarker(s) – ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE
• Sponsor – F. Hoffmann – La Roche Ltd IQVIA

23308- A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER

• Phase – II
• Stage(s) – Recurrent or Metastatic Disease not Amenable to Curative Therapy
• Line of Therapy – 3+
• Investigational Drug – alisertib administered in combination with endocrine therapy
• Drug Class – benzazepine, an organic compound that contains a benzene ring fused to an azepine ring. It’s also an antineoplastic drug and an inhibitor of Aurora A kinase
• Mechanism of Action – selective inhibiting Aurora A Kinase
• Biomarker(s) – HR+, HER2-

24151- 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)(STML-ELA-0422)

• Phase – III
• Stage(s) – Early Breast Cancer with High Risk of Recurrence
• Line of Therapy – Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK4/6i and with or without an LHRH agonist. Participants who received prior CDK4/6i or a poly ADP-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments
  – Participants are to be between 2 to 6 years from the date of curative surgical resection
• Investigational Drug – elacestrant
• Drug Class – benzazepine, an organic compound that contains a benzene ring fused to an azepine ring. It’s also an antineoplastic drug and an inhibitor of Aurora A kinase
• Mechanism of Action – Elacestrant is an oral SERD and ER antagonist
• Biomarker(s) – ER+, HER-
• Sponsor – Stemline Therapeutics, Inc.

24169- A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206) (JZP598-206)

• Phase – II
• Stage(s) – locally advanced, unresectable, or metastatic solid tumors
• Line of Therapy – Participants in all cohorts must have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit
• Investigational Drug – zanidatamab
• Mechanism of Action – Zanidatamab is a bispecific, HER2-directed antibody
• Biomarker(s) – HER2 IHC 3+ overexpression