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    DRUG:

    Trazimera (trastuzumab-qyyp)

    i
    Other names: PF-05280014, PF-5280014, PF 05280014, PF 5280014, PF05280014, PF5280014
    Company:
    Pfizer
    Drug class:
    HER2 inhibitor
    Related drugs:
    1m
    Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    2ms
    Safety and Efficacy of Trastuzumab BS (clinicaltrials.gov)
    P=N/A, N=150, Active, not recruiting, Pfizer | Trial completion date: Sep 2025 --> Feb 2025 | Trial primary completion date: Sep 2025 --> Feb 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Trazimera (trastuzumab-qyyp)
    3ms
    ACCRU-GI-2003: Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study (clinicaltrials.gov)
    P2; Trial completion date: May 2029 --> Sep 2024 | Trial primary completion date: May 2025 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation • HER-2 amplification • PIK3CA mutation • BRAF V600
    |
    Guardant360® CDx
    |
    Tukysa (tucatinib) • Lonsurf (trifluridine/tipiracil) • Trazimera (trastuzumab-qyyp)
    4ms
    Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (clinicaltrials.gov)
    P1, N=28, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp) • pepinemab (VX15)
    4ms
    Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (clinicaltrials.gov)
    P3; Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    paclitaxel • docetaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Trazimera (trastuzumab-qyyp)
    4ms
    CALGB-40601: Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery (clinicaltrials.gov)
    P3, N=305, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    paclitaxel • lapatinib • Trazimera (trastuzumab-qyyp)
    5ms
    TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Mayo Clinic | Trial completion date: Jul 2024 --> Dec 2025
    Trial completion date • Combination therapy • Metastases
    |
    Herceptin (trastuzumab) • paclitaxel • fulvestrant • letrozole • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    5ms
    ACCRU-GI-2003: Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study (clinicaltrials.gov)
    P2; N=30 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: May 2024 --> May 2025
    Trial primary completion date • Enrollment change • Trial withdrawal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
    |
    Guardant360® CDx
    |
    Tukysa (tucatinib) • Lonsurf (trifluridine/tipiracil) • Trazimera (trastuzumab-qyyp)
    5ms
    Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=24, Suspended, Veana Therapeutics | Trial completion date: Feb 2025 --> Feb 2030 | Recruiting --> Suspended | Trial primary completion date: Feb 2024 --> Feb 2028
    Trial completion date • Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Vimo (alpha-tocopheroloxyacetic acid)
    6ms
    Disrupting EGFR-HER2 Transactivation by Pertuzumab in HER2-Positive Cancer: Quantitative Analysis Reveals EGFR Signal Input as Potential Predictor of Therapeutic Outcome. (PubMed, Int J Mol Sci)
    Overall, the data demonstrated that pertuzumab, by hindering post-stimulus interaction between EGFR and HER2, inhibits EGFR-evoked HER2 aggregation and phosphorylation and leads to a dose-dependent decrease in cell proliferation, particularly when higher amounts of EGF are present. Consequently, we propose that EGFR expression on HER2-positive tumors could be taken into consideration as a potential biomarker when predicting the outcome of pertuzumab treatment.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    6ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    7ms
    NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, National Cancer Institute (NCI) | N=600 --> 190 | Trial completion date: Apr 2024 --> May 2025
    Enrollment change • Trial completion date • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IL2 (Interleukin 2)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • docetaxel • Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar)
    8ms
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Phase classification: P1b --> P1/2 | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 amplification
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    9ms
    Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (clinicaltrials.gov)
    P3, N=2014, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive
    |
    Trazimera (trastuzumab-qyyp)
    9ms
    Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    carboplatin • docetaxel • Trazimera (trastuzumab-qyyp) • goserelin acetate • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar)
    9ms
    Bispecific immune cell engager enhances the anticancer activity of CD16+ NK cells and macrophages in vitro, and eliminates cancer metastasis in NK humanized NOG mice. (PubMed, J Immunother Cancer)
    Collectively, our in vivo findings underscore BiKE:E5C1's potential as an immune cell engager capable of activating immune cells for cancer cell elimination, thereby expanding the arsenal of available BiKEs for cancer immunotherapy.
    Preclinical • Journal • Immune cell
    |
    HER-2 (Human epidermal growth factor receptor 2) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp)
    9ms
    SCHOLAR-2: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (clinicaltrials.gov)
    P2, N=130, Recruiting, Population Health Research Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    10ms
    Biosimilar in Breast Cancer: A Narrative Review. (PubMed, Cureus)
    Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Kanjinti (trastuzumab-anns) • Trazimera (trastuzumab-qyyp)
    10ms
    Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar)
    10ms
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    10ms
    TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=80 --> 19
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • fulvestrant • letrozole • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    10ms
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov)
    P4, N=10, Recruiting, City of Hope Medical Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
    10ms
    SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Jun 2024 --> Nov 2024
    Trial completion date • Surgery • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • HER-2 amplification • BRAF V600 • KRAS exon 4 mutation • BRAF exon 15 mutation
    |
    Herceptin (trastuzumab) • Erbitux (cetuximab) • Perjeta (pertuzumab) • irinotecan • Trazimera (trastuzumab-qyyp)
    11ms
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    1year
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    1year
    Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=43, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1b --> P1/2
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • PTEN mutation + HR positive
    |
    paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Trazimera (trastuzumab-qyyp)
    1year
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    1year
    Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar)
    1year
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=2, Terminated, National Cancer Institute (NCI) | N=12 --> 2 | Recruiting --> Terminated; Inadequate accrual rate
    Enrollment change • Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    HR positive • PIK3CA mutation • PTEN mutation
    |
    Herceptin (trastuzumab) • Aliqopa (copanlisib) • Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar)
    over1year
    Safety and Efficacy of Trastuzumab BS (clinicaltrials.gov)
    P=N/A, N=150, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Trazimera (trastuzumab-qyyp)
    over1year
    Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer (clinicaltrials.gov)
    P3, N=203, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    carboplatin • paclitaxel • Trazimera (trastuzumab-qyyp)
    over1year
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2023 --> Dec 2023
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    over1year
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=25, Not yet recruiting, OHSU Knight Cancer Institute | Phase classification: P2 --> P1 | N=131 --> 25
    Phase classification • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • EG1206A (pertuzumab biosimilar)
    over1year
    FASN Inhibitor TVB-2640 and Trastuzumab in Combination With Paclitaxel or Endocrine Therapy for the Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Mayo Clinic | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial primary completion date
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • fulvestrant • letrozole • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    over1year
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • IGFBP2 (Insulin-like growth factor binding protein 2)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    over1year
    Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer (clinicaltrials.gov)
    P=N/A, N=132, Active, not recruiting, Albert Einstein College of Medicine | Trial completion date: Jun 2023 --> Dec 2026 | Trial primary completion date: Jun 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Trazimera (trastuzumab-qyyp)
    over1year
    Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov)
    P1, N=39, Suspended, Mayo Clinic | Trial completion date: May 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Apr 2025
    Trial completion date • Trial primary completion date • FDG PET • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • Aliqopa (copanlisib) • Darzalex (daratumumab) • Herzuma (trastuzumab-pkrb) • carfilzomib • Istodax (romidepsin) • Trazimera (trastuzumab-qyyp) • Beleodaq (belinostat)
    over1year
    Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy (clinicaltrials.gov)
    P1/2, N=31, Completed, University of Washington | Unknown status --> Completed
    Trial completion • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • NCAM1 (Neural cell adhesion molecule 1) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp) • AST-301
    over1year
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    HER-2 amplification • PTPRC expression • IL6 expression
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    over1year
    A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) (clinicaltrials.gov)
    P2; Unknown status --> Completed | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Aug 2021 --> May 2022
    Combination therapy • Trial completion date • Trial primary completion date • Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 amplification • PGR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Keytruda (pembrolizumab) • Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    almost2years
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2021 --> Jun 2023
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    almost2years
    CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov)
    P2, N=2156, Recruiting, ECOG-ACRIN Cancer Research Group | Trial completion date: Feb 2023 --> Dec 2038 | Trial primary completion date: Feb 2023 --> Oct 2026
    Trial completion date • Trial primary completion date • Surgery • Pre-surgery
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • albumin-bound paclitaxel • Trazimera (trastuzumab-qyyp)