University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
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 9 Trials 
24 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Hurvitz, Sara
ENABLAR-2, NCT05065411: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

Terminated
3
5
US
Enobosarm & Abemaciclib Combo, VERU-024, Verzenio, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant, exemestane, fulvestrant, exemestane plus everolimus
Veru Inc.
Metastatic Breast Cancer
10/23
01/24
postMONARCH, NCT05169567 / 2021-002301-10: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Active, not recruiting
3
368
Europe, US, RoW
Abemaciclib, Fulvestrant, Placebo
Eli Lilly and Company, Eli Lilly and Company
Breast Neoplasm, Neoplasm Metastasis
02/24
02/26
FLAMINGO-01, NCT05232916: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects

Recruiting
3
750
Europe, US
Placebo, GLSI-100
Greenwich LifeSciences, Inc.
Breast Cancer
12/26
12/26
NCT02668939: Presurgical Treatment With Single-Agent Trastuzumab or Lapatinib or the Combination of Trastuzumab and Lapatinib, Followed by Six Cycles of Docetaxel & Carboplatin With Trastuzumab or Lapatinib or the Combination of Trastuzumab and Lapatinib in Patients With HER2/+ Operable Breast Cancer

Active, not recruiting
2
140
US
TCH, Trastuzumab, Docetaxel, carboplatin, TCTy, Lapatinib, docetaxel, TCHTy, lapatinib
Translational Oncology Research International, Sanofi, GlaxoSmithKline
Adenocarcinoma of the Breast, Tumor HER2/Neu Positive
01/16
 
NCT05113966: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Checkmark Data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Data from P2 trial for locally advanced or metastatic TNBC
Checkmark Presentation of data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Presentation of data from P2 trial for locally advanced or metastatic TNBC
Terminated
2
30
US
Trilaciclib, G1T28, CDK 4/6 inhibitor, Sacituzumab Govitecan-hziy, Trodelvy, IMMU-132
G1 Therapeutics, Inc.
Triple Negative Breast Cancer
11/23
06/24
HER2CLIMB-04, NCT04539938: A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Active, not recruiting
2
70
US
tucatinib, TUKYSA, ARRY-380, ONT-380, trastuzumab deruxtecan, T-DXd, Enhertu, DS-8201
Seagen Inc.
HER2 Positive Breast Cancer
07/24
10/25
TRIO-US B-12 TALENT, NCT04553770: Trastuzumab Deruxtecan Alone or in Combination with Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

Checkmark Presentation of data from TALENT trial for HER2 Low, HR+ breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from TALENT trial for HER2 Low, HR+ breast cancer at SABCS 2022
Recruiting
2
88
US
Anastrozole, Anastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan, DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, WHO 10516
Jonsson Comprehensive Cancer Center, Translational Research in Oncology-U.S, Daiichi Sankyo Co., Ltd.
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
09/25
09/25
ZWI-ZW25-204, NCT05027139: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

Active, not recruiting
1/2
52
US
Zanidatamab, ZW25, JZP598, Evorpacept, ALX148
Jazz Pharmaceuticals, ALX Oncology Inc.
HER2-expressing Cancers
04/25
09/25
NCT05511844: Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors

Active, not recruiting
1
87
US
ORM-5029
Orum Therapeutics USA, Inc.
HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
04/25
10/25
Jimenez, Antonio
Precision-T (PhIII component), NCT05316701: Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting
3
174
US
Orca-T, Standard-of-Care, SOC
Orca Biosystems, Inc.
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
04/25
04/27
Precision-T, NCT04013685: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting
1
255
US
Orca-T
Orca Biosystems, Inc.
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
07/24
07/26
NCT06158100: Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Recruiting
1
25
US
Venetoclax, Venclexta, Venclyxto, Azacitidine, Vidaza, Azadine, Donor Lymphocyte Infusion
Antonio M Jimenez Jimenez, AbbVie
Acute Myeloid Leukemia
12/26
12/27
Valdes-Albini, Frances
CompassHER2 RD, NCT04457596: T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the Trial

Calendar Jan 2028 - Dec 2028: From CompassHER2 RD trial in combination with Kadcyla for HER2+ breast cancer
Recruiting
3
1031
Canada, US
Trastuzumab Emtansine, Placebo Administration, Tucatinib, Questionnaire Administration, Quality-of-Life Assessment
Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI), Seagen Inc.
Anatomic Stage IA Breast Cancer AJCC V8, Anatomic Stage II Breast Cancer AJCC V8, Anatomic Stage IIA Breast Cancer AJCC V8, Anatomic Stage IIB Breast Cancer AJCC V8, Anatomic Stage III Breast Cancer AJCC V8, Anatomic Stage IIIA Breast Cancer AJCC V8, Anatomic Stage IIIB Breast Cancer AJCC V8, Anatomic Stage IIIC Breast Cancer AJCC V8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC V8, Prognostic Stage IA Breast Cancer AJCC V8, Prognostic Stage IB Breast Cancer AJCC V8, Prognostic Stage II Breast Cancer AJCC V8, Prognostic Stage IIA Breast Cancer AJCC V8, Prognostic Stage IIB Breast Cancer AJCC V8, Prognostic Stage III Breast Cancer AJCC V8, Prognostic Stage IIIA Breast Cancer AJCC V8, Prognostic Stage IIIB Breast Cancer AJCC V8, Prognostic Stage IIIC Breast Cancer AJCC V8, Synchronous Bilateral Breast Carcinoma
01/28
05/35
Meyer, Everett
Precision-T (PhIII component), NCT05316701: Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting
3
174
US
Orca-T, Standard-of-Care, SOC
Orca Biosystems, Inc.
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Undifferentiated Leukemia, Myelodysplastic Syndrome, Acute Leukemia, Therapy-Related Myelodysplastic Syndrome
04/25
04/27
NCT06138132: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis

Recruiting
1
12
US
KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen, Bendamustine
Stanford University, Kyverna Therapeutics
Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
06/27
06/27
Precision-T, NCT04013685: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting
1
255
US
Orca-T
Orca Biosystems, Inc.
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia
07/24
07/26
NCT05088356: Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Recruiting
1
40
US
Purified regulatory T-cells (Treg) plus CD34+ HSPC, Fludarabine, Beneflur, SH T 586, fludarabine monophosphate, Melphalan, Melphalanum, CliniMACS CD34 Reagent System, Tacrolimus, Prograf, Advagraf, fujimycin, Cyclophosphamide, alkylating agent, Plerixafor, Mozobil, AMD 3100, LM-3100, Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent, filgrastim XM02, Thiotepa, Tepandina, Mycophenolate Mofetil (MMF), CellCept, Ruxolitinib, Jakafi
Stanford University, Orca Biosystems, Inc.
Allogeneic Hematopoietic Cell Transplantation (HCT), Advanced Hematologic Malignancies, Acute Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
12/25
12/25
Huppert, Laura
FLAMINGO-01, NCT05232916: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects

Recruiting
3
750
Europe, US
Placebo, GLSI-100
Greenwich LifeSciences, Inc.
Breast Cancer
12/26
12/26
BRIDGET, NCT05323955: Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients with ADvanced Human Epidermal Growth Factor Receptor 2+ BrEast Cancer with the Addition of Tucatinib

Recruiting
2
48
US
Trastuzumab, Herceptin, Trastuzumab Emtansine (T-DM1), Pertuzumab, Perjeta, Tucatinib, Tukysa
Carey Anders, M.D., Pfizer
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
10/26
10/27
NCT06224673: ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting
2
36
US
ARX788, Anvatabart Opadotin, Antibody-drug Conjugate ARX788, Anti-Her2 Mab PAF- MMAF Toxin Oxime Conjugate ARX-788, Anti-Her2 ADC, Computed Tomography (CT), CT Scan, PET/CT, Biospecimen Collection, Specimen Collection, Biological Sample Collection, Amiloride, Amiloride Topical Eye Drops
Laura Huppert, MD, BA, Ambrx, Inc.
HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma
07/28
07/28
ENCORE, NCT06774027: Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

Not yet recruiting
N/A
100
US
Specimen collection, Biospecimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Non-Investigational ADC, Medical Record Review, Medical Chart Review
University of California, San Francisco, Translational Breast Cancer Research Consortium, Gilead Sciences, Johns Hopkins University
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Metastatic Breast Cancer, HR+ HER2 Breast Cancer, Metastatic Triple Negative Breast Cancers, Metastatic Triple-Negative Breast Carcinoma
12/30
12/30
NCT05105100: Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma

Recruiting
N/A
25
US
Biopsy, Excisional Biopsy, Biospecimen Collection, Specimen Collection
University of California, San Francisco, Merck Sharp & Dohme LLC
Melanoma, Advanced Melanoma
08/26
08/26
Yoshinaga, Jessica
FLAMINGO-01, NCT05232916: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects

Recruiting
3
750
Europe, US
Placebo, GLSI-100
Greenwich LifeSciences, Inc.
Breast Cancer
12/26
12/26
Master, Aashni
FLAMINGO-01, NCT05232916: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects

Recruiting
3
750
Europe, US
Placebo, GLSI-100
Greenwich LifeSciences, Inc.
Breast Cancer
12/26
12/26

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