trastuzumab/pertuzumab (EG13084) / EirGenix - LARVOL DELTA

Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer. (PubMed, N Engl J Med) - P3 | "Trastuzumab deruxtecan plus pertuzumab led to a significantly lower risk of progression or death than THP when used as first-line treatment for HER2-positive advanced or metastatic breast cancer, with no new safety signals. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast09 ClinicalTrials.gov number, NCT04784715.)."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Radiation Therapy Followed by Intrathecal (IT) Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease: Interim Results from a Phase II Multi-Institutional Study (SABCS 2025) - P1/2 | "The study met its predetermined endpoint for OS to warrant continuing enrollment in the second stage of the phase II trial. Initial trial results are encouraging with study therapy that is well tolerated."

Clinical • P2 data • Breast Cancer • HER-2

Proactive brain screening using contrast-enhanced brain CT scans in HER2+ metastatic breast cancer. (PubMed, Clin Cancer Res) - "Brain screening with CT scans was associated with fewer symptomatic BMs and better performance status at BM diagnosis, supporting proactive imaging in HER2+ mBC. Prospective studies are warranted to define optimal timing and imaging modalities."

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

HER2CLIMB-05: A Phase 3 Study of Tucatinib Versus Placebo in Combination with Trastuzumab and Pertuzumab as First-line Maintenance Therapy for HER2+ Metastatic Breast Cancer. (PubMed, J Clin Oncol) - P3 | "Tucatinib addition to trastuzumab and pertuzumab demonstrated improvement in PFS with no new safety signals identified and may be an option for 1L maintenance therapy in patients with HER2+ MBC."

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

EPIK-B2: Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (clinicaltrials.gov) - P3 | N=19 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Multiplex Spatial Proteomic Analysis of HER2-Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response. (PubMed, JCO Precis Oncol) - "ER-negative, HER2-positive breast cancer has unique molecular and immunologic features that may predict pCR after neoadjuvant HP. Validation of these potential biomarkers and composite biomarker analyses may guide design of future clinical trials."

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

HCB101-201: Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=500 | Active, not recruiting | Sponsor: FBD Biologics Limited | Recruiting ➔ Active, not recruiting | N=150 ➔ 500

Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed

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

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Oct 2027 ➔ Apr 2025 | Trial primary completion date: Oct 2027 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • NRG1

Peripheral immune profiling during neoadjuvant HER2-targeted therapy in HER2-positive (HER2+) early breast cancer (EBC): Mass cytometry (CyTOF) analysis from the MARGOT trial (SABCS 2025) - P2 | " The investigator-initiated MARGOT trial (NCT04425018/TBCRC052) randomized 171 patients with stage II-III HER2+ EBC 1:2 to receive neoadjuvant THP (trastuzumab/pertuzumab/paclitaxel) or TMP (margetuximab/pertuzumab/paclitaxel). Neoadjuvant chemotherapy plus anti-HER2 therapy induces early changes in circulating immune populations in HER2+ EBC. PBMC profiling reveals a rapid decline in circulating monocytes and NK cell subsets after 3 weeks of therapy, potentially reflecting tumor migration and contribution to ADCC."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD8

Health care policies, drug costs, and time toxicities in biologics for HER2-positive breast cancer: cost minimization analysis of direct and indirect costs. (PubMed, ESMO Real World Data Digit Oncol) - "The utilization of s.c. pertuzumab/trastuzumab/hyaluronidase rose from 0 to 87 doses/month, with a consequent decline in the usage of i.v. pertuzumab/trastuzumab...Reducing time toxicity and extending care to the community is pivotal to cancer patients with constrained timeframes. These findings provide valuable insights for decision making in health care policy and negotiations with drug companies to ensure s.c. formulations are affordable."

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

Anti-HER2-targeted therapies: effects on human in vitro blood-brain barrier models. (PubMed, Front Drug Deliv) - "Established therapies such as trastuzumab, pertuzumab, trastuzumab/pertuzumab, lapatinib and tucatinib are widely used and are selectively toxic to HER2-positive breast cancer cell line. In conclusion, we demonstrate different time- and concentration-dependent effects of anti-HER2-targeted therapies for the treatment of advanced HER2-positive breast cancer on the BBB in vitro. Further experiments are required to assess the clinical relevance of our results."

Journal • Preclinical • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ABCB1 • ABCG2 • CCL2 • CD34 • CLDN5 • OCLN • SLC2A1

Pathologic Complete Response Rates in Early-Stage Human Epidermal Growth Factor 2 (HER2)-Positive Breast Cancer Treated With Neoadjuvant Chemotherapy and Anti-HER2 Therapy: A Real-World Experience. (PubMed, Cureus) - "Trastuzumab, the first humanized monoclonal antibody targeting the extracellular domain of HER2, improves both pCR and event-free survival when added to standard regimens. Pertuzumab, which binds to domain II of HER2 and inhibits HER2-HER3 dimerization, provides complementary activity...However, emerging predictive biomarkers are currently under investigation to further optimize escalation and de-escalation treatment strategies. Future studies on larger cohorts incorporating these additional biomarkers are needed to enhance predictive models and guide personalized therapy."

Journal • Real-world evidence • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ERBB3

Association of statin use on survival outcomes of patients with early-stage HER2-positive breast cancer in the APHINITY trial. (PubMed, Breast Cancer Res Treat) - "In APHINITY, statin use was not associated with improved survival outcomes. These results must be interpreted with caution due to the exploratory nature of the analysis and the associated limitations."

Journal • Breast Cancer • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • HER-2

A pilot study incorporating HER2-directed dendritic cells into neoadjuvant therapy of early stage HER2+ER- breast cancer. (PubMed, NPJ Breast Cancer) - P1 | "Stage II-III ER-HER2+ breast cancer patients prescribed neoadjuvant docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP) were enrolled. Immunofluorescence showed increased T cell infiltration following IT + IN injections. Additional IT HER2-DC1 investigation is warranted."

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

Reducing treatment burden in HER2+ breast cancer: Evaluating subcutaneous injection methods for pertuzumab/trastuzumab combination therapy. (PubMed, Medicine (Baltimore)) - "This retrospective analysis suggests that using a slow bolus injection with an infusion pump may reduce local adverse reactions following subcutaneous administration of pertuzumab and trastuzumab in patients with HER2-positive breast cancer. The standardized use of infusion pumps could enhance patient comfort, safety, and overall treatment experience."

Journal • Observational data • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

A Case of T4b Breast Cancer That Developed 17 Years after Radiofrequency Ablation (PubMed, Gan To Kagaku Ryoho) - "After that, trastuzumab+pertuzumab was administered 17 times. Currently, the patient is being followed up with fulvestrant. Two years after surgery, there has been no obvious metastasis or recurrence."

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

Phase III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk or pertuzumab, trastuzumab, and hyaluronidase-zzxf in HER2 positive, stage I-IV endometrial carcinoma (NRG-GY026) (SGO 2026) - No abstract available

P3 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

Inhibition of HER2 signaling and breast cancer cell growth with a novel antibody targeting HER2 ECD III/IV. (PubMed, PLoS One) - "We also determined the cryo-EM structures of the HER2-m66-trastuzumab ternary complex and the HER2-r40-trastuzumab-pertuzumab tetrameric complex, at overall resolutions of 3.2 Å and 3.1 Å, respectively. Structural analyses reveal that m66 recognizes an epitope overlapping with that of pertuzumab, whereas r40 binds within the HER2 ECD III/IV-a region distinct from the binding sites of both trastuzumab and pertuzumab. These findings identify r40 as a promising therapeutic candidate for use in combination with trastuzumab and pertuzumab in the treatment of HER2-positive breast cancer."

Journal • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

TAYLOR: Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

ctDNA in HER2+ EBC Neoadjuvant Treatment (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

Circulating tumor DNA • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dual Anti-HER2 Combination with Chemotherapy as First-line Treatment for HER2-positive Metastatic Breast Cancer. (PubMed, Acta Med Indones) - "She received initial treatment with dual anti-HER2 (Pertuzumab, Trastuzumab) and Docetaxel every 3 weeks for six cycles, followed by maintenance therapy with Pertuzumab and Trastuzumab. PET scan evaluations showed an excellent response, with complete resolution of the primary lesion and substantial regression of metastases. The CLEOPATRA trial supports the efficacy of a combination of dual anti-HER2 and Docetaxel, showing prolonged progression-free and overall survival. The combination of dual anti-HER2 enhanced antitumor efficacy by providing dual inhibition of HER2. This case highlights the pivotal role of dual anti-HER2 therapy combined with chemotherapy in improving survival outcomes of patients with metastatic HER2-positive breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • 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

Efficacy and Safety of Subcutaneous Pertuzumab-Trastuzumab (Phesgo) in Neoadjuvant Treatment of HER2-positive Breast Cancer: Real-world Data from Japan. (PubMed, Anticancer Res) - "Phesgo demonstrated comparable or superior efficacy and favorable safety with markedly improved treatment efficiency in real-world Japanese practice. Phesgo represents a promising alternative to intravenous administration, reducing patient burden and optimizing healthcare resource utilization."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Oncology • Pruritus • Solid Tumor • HER-2

MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov) - P1/2 | N=316 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2027 ➔ May 2029 | Trial primary completion date: Nov 2027 ➔ May 2029

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER