Trazimera (trastuzumab-qyyp) / Pfizer - LARVOL DELTA

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Minimal residual disease • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

NRG-HN010: Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers (clinicaltrials.gov) - P2 | N=146 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Jul 2028 ➔ Jul 2032

Trial completion date • Oncology • Salivary Gland Cancer • HER-2

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Mar 2026

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: May 2026 ➔ Apr 2027 | Trial primary completion date: May 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

EA1181: CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov) - P2 | N=2175 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • ER • PGR

Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer (clinicaltrials.gov) - P2 | N=92 | Completed | Sponsor: University of Nebraska | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Nov 2025

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1 | N=28 | Suspended | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Suspended | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial primary completion date • Trial suspension • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=190 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; Inadequate accrual rate

Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Aug 2026 ➔ Dec 2026 | Trial completion date: Aug 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2027 ➔ Apr 2028 | Trial primary completion date: Apr 2026 ➔ Apr 2027 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis (clinicaltrials.gov) - P3 | N=562 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

EAY131-J: 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 | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2

2022-009: A randomized, double-blinded, placebo-controlled, multicenter, phase II/III efficacy and safety study of oral TherO2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with Metastatic Breast CancernTherO2-01S22 in HER2-positive breast cancer: TherO2-MBC Study (clinicaltrialsregister.eu) - P2/3 | N=224 | Not yet recruiting | Sponsor: Centre Regional Lutte Contre Le Cancer

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

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 | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Feb 2026 ➔ May 2026 | Trial primary completion date: Feb 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

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 | Completed | Sponsor: SWOG Cancer Research Network | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Jul 2025

Trial completion • Trial completion date • Breast Cancer • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center

Minimal residual disease • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

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 | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=190 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

Incidence of hypersensitivity reactions in patients receiving trastuzumab biosimilars (SABCS 2025) - "Accordingly, MD Anderson Cancer Center updated its formulary from trastuzumab (Herceptin®) to trastuzumab biosimilars: trastuzumab-qyyp (Trazimera®) and trastuzumab-anns (Kanjinti®), with trastuzumab-qyyp designated as the preferred agent. The incidence and severity of HSRs were higher in patients receiving biosimilar trastuzumab products compared to the reference product. Data collection for patients without documented trastuzumab allergies is ongoing. Based on this analysis, a prospective study utilizing prophylactic medications is being planned."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • HER-2

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: University of Nebraska | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Dec 2025

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Oct 2025 ➔ Aug 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

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 | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2025 ➔ Sep 2026

Biomarker • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2