Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) / Roche, Halozyme - LARVOL DELTA

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Jun 2026 ➔ Dec 2026

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

ATEMPT 2.0: Adjuvant T-DM1 vs TH (clinicaltrials.gov) - P2 | N=500 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: May 2028 ➔ May 2029 | Trial primary completion date: Nov 2026 ➔ Nov 2028

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

Audit of Time Delays in Administration of Subcutaneous Trastuzumab in the Oncology Day Care Unit. Are we really saving time? (ESMO 2026) - No abstract available

Oncology

Optimizing Cancer Care Delivery: Capacity and Cost Benefits of Home-Based Self-Administration of Subcutaneous Trastuzumab (ESMO 2026) - No abstract available

HEOR • Oncology

FcBP-HFQ lipid-mediated trastuzumab modification of mRNA-loaded lipid nanoparticles enhances delivery to HER2-expressing cancer cells. (PubMed, Eur J Pharm Sci) - "Furthermore, after intratumoral administration in a mouse model bearing subcutaneous SKOV-3 tumors, the trastuzumab-modified group showed significantly higher luciferase expression than the unmodified and isotype-controlled antibody-modified groups. These findings support FcBP-HFQ lipid-mediated trastuzumab modification of LNPs as a useful approach for efficient cell-selective mRNA delivery."

IO biomarker • Journal • Breast Cancer • Genetic Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Respiratory Diseases • Solid Tumor • HER-2

Final analysis of the FeDeriCa phase III study: long-term efficacy, safety and pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection, plus chemotherapy, in HER2-positive early breast cancer. (PubMed, ESMO Open) - P3 | "Long-term efficacy of PH FDC SC and P + H IV was comparable. Safety remained similar and consistent with P + H + chemotherapy. PH FDC SC is established as a faster, more convenient, less invasive patient- and health care professional-preferred alternative to P + H IV for HER2-positive BC."

Journal • P3 data • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov) - P1 | N=331 | Completed | Sponsor: Genentech, Inc. | Active, not recruiting ➔ Completed

Trial completion

Tucatinib + subcutaneous (SC) trastuzumab (Tuc + Trast SC) in patients (pts) with solid tumors with ERBB2 alterations (alts): Results from the targeted agent and profiling utilization registry (TAPUR) study. (ASCO 2026) - P2 | "Tuc + Trast SC demonstrated antitumor activity in pts with advanced solid tumors with ERBB2 alts, warranting additional study. Demographics (N=78) and efficacy outcomes (n=75)."

Clinical • Back Pain • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Immunology • Musculoskeletal Pain • Nephrology • Oncology • Renal Disease • Respiratory Diseases • Solid Tumor • Systemic Inflammatory Response Syndrome • Urothelial Cancer • HER-2 • TNNI3

Early results of neoadjuvant therapy with pyrotinib, subcutaneous trastuzumab, and capecitabine for HER2-positive early breast cancer from a prospective, single-arm, multicenter trial. (ASCO 2026) - P2 | "The fully non-intravenous neoadjuvant regimen combining pyrotinib, SC trastuzumab, and capecitabine is an efficacious and safe regimen for patients with low- to intermediate-risk HER2-positive early breast cancer. This regimen offers a more convenient and less burdensome treatment for this patient population, potentially improving quality of life and treatment adherence."

Clinical • Anorexia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

The value of time savings in breast cancer therapy for patients and healthcare providers: the subcutaneous injection of pertuzumab and trastuzumab fixed-dose combination at a tertiary care center in the UAE. (PubMed, J Comp Eff Res) - " PH FDC SC was associated with significant time savings for both patients and healthcare providers. The transition to SC administration unlocked 2468.25 clinical hours annually, translating into notable indirect cost reductions through optimized resource utilization and improved operational efficiency compared with IV administration."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Pragmatic Clinical Trial Assessing Response to Neoadjuvant Docetaxel and Trastuzumab in Nigerian Women With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer (ARETTA). (PubMed, JCO Glob Oncol) - "This phase II study showed that neoadjuvant chemotherapy with T + scH resulted in pCR of 53%, surpassing the planned cutoff for success of 40%. This is comparable with the rates and other efficacy end points that follow data from phase II international trials. This regimen may be useful in the absence of pertuzumab and warrants further investigation."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov) - P1 | N=312 | Active, not recruiting | Sponsor: Genentech, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Real-World adherence and quality of life Among HER2-positive breast cancer patients receiving subcutaneous trastuzumab in Ghana: A pilot study. (PubMed, J Oncol Pharm Pract) - "No significant predictors of adherence were identified.ConclusionAdherence to subcutaneous trastuzumab was generally high; however, structural and symptom-related barriers persist. Targeted measures, including structured adherence support is needed to optimize treatment continuity."

HEOR • Journal • Real-world evidence • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

Title results of the safety run-in part of the TUC-TOC phase II trial (NCT05955170): Tucatinib in combination with oral etoposide (VP16) - trastuzumab in patients with metastatic HER2-positive breast cancer (HER2+ mBC) (ESMO-BC 2026) - P2 | "Background: Tucatinib combined with capecitabine and trastuzumab is a standard therapy for HER2+ mBC; data on tucatinib rechallenge are lacking...The primary endpoint of the safety run-in was the rate of dose-limiting toxicities (DLTs) among the first six evaluable patients receiving oral VP16 50 mg (days 1–14, q3w), subcutaneous trastuzumab 600 mg q3w, and oral tucatinib 300 mg twice daily... The TUC-TOC safety run-in demonstrated a favorable safety profile, supporting continuation of the trial. The primary efficacy endpoint, best objective response rate within the first 6 months, will be reported after enrollment of 55 evaluable patients."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • TOP2A

The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study. (PubMed, Int J Clin Oncol) - P3 | "The study met the co-primary endpoints of non-inferiority of cycle 7 serum Ctrough for pertuzumab and trastuzumab for PH FDC SC vs. P + H IV. tpCR rates and safety were comparable between arms. PH FDC SC may be a viable treatment option for Chinese patients with HER2-positive eBC."

Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov) - P1 | N=200 | Completed | Sponsor: Celltrion | Active, not recruiting ➔ Completed

Trial completion

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Daiichi Sankyo | N=25 ➔ 76

Enrollment change • Trial initiation date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Real-world evidence on the use of hospital resources for subcutaneous and intravenous trastuzumab administration in breast cancer patients at a referral public hospital in Mexico. (PubMed, J Comp Eff Res) - " In a routine public oncology setting with limited resources, the use of SC trastuzumab was associated with clear advantages in terms of efficiency and the treatment experience while also mitigating the workload of infusion areas. These results provide practical, context-specific evidence that could help healthcare systems to improve the organization of oncology services and make better use of scarce hospital resources."

HEOR • Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Daiichi Sankyo

New P1 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Biocon Biologics UK PLC | Not yet recruiting ➔ Recruiting

Enrollment open

The lymphatic system plays a major role in the absorption of subcutaneously administered trastuzumab in a lymph-duct cannulated rat model (AACR 2025) - "The study confirms the lymphatics is the main absorption pathway following subcutaneous administration of trastuzumab, regardless of the formulation type (IV or SC). This results in markedly high concentrations of trastuzumab in the draining lymphatics, and the co-localization of the drug molecules with potentially disseminated tumor cells and immune cells within the tumor-draining lymphatics may provide an opportunity for enhanced therapeutic outcomes."

Preclinical • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor

Updated cost comparison of home care subcutaneous versus outpatient intravenous trastuzumab for HER2-positive breast cancer in Singapore. (PubMed, Ther Adv Med Oncol) - "While service delivery (manpower, facility, consumables) and productivity loss remained cheaper in home care, drug cost is the dominant factor of overall expenditure in trastuzumab delivery. At current drug prices, outpatient IV trastuzumab administration is the cost-saving option, compared with home care SC trastuzumab."

HEOR • Journal • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Adrienne G. Waks | Recruiting ➔ Active, not recruiting | N=40 ➔ 28

Enrollment change • Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DS8201-801: Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial. (clinicaltrialsregister.eu) - P1 | N=20 | Recruiting | Sponsor: Daiichi Sankyo Inc.

New P1 trial • Oncology • Solid Tumor

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study (clinicaltrials.gov) - P2 | N=462 | Active, not recruiting | Sponsor: Borstkanker Onderzoek Groep | Trial primary completion date: May 2022 ➔ Nov 2022

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