trastuzumab/pertuzumab (EG13084) / EirGenix - LARVOL DELTA

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

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

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

Tumor mutations predict HER2-targeted therapy resistance in primary HER2-positive breast cancer. (PubMed, NPJ Breast Cancer) - "In HER2+ breast cancer, PIK3CA mutations were significantly associated with reduced response to dual HER2 blockade with pertuzumab+trastuzumab as well as reduced response to nab-paclitaxel. This reduction was not observed in GeparTrio without anti-HER2 therapy."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • EGFR • HRAS • KRAS • NRAS • PIK3CA • TP53

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

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

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

BRIDGET: 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 (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Carey Anders, M.D. | Trial completion date: Oct 2027 ➔ Jul 2026 | Trial primary completion date: Oct 2026 ➔ Apr 2026

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

Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase 3 trial. (PubMed, Ann Oncol) - P3 | "Neoadjuvant T-DXd-THP demonstrated statistically significant and clinically meaningful pCR benefit and improved safety versus ddAC-THP."

Journal • P3 data • Breast Cancer • Cardiovascular • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Peking Union Medical College | Trial primary completion date: Jul 2026 ➔ Jul 2028

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

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=1800 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Hebei Medical University Fourth Hospital

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

Pathological Response to Herceptin-containing Neoadjuvant Therapy in HER2 IHC2+/ISH+ and IHC3+ Early-Stage Invasive Ductal Carcinoma. (PubMed, Hum Pathol) - "Compared with IHC 3+ IDC, IHC 2+/FISH+ IDC demonstrated lower pCR rates and inferior RFS in hormone receptor-negative subset following neoadjuvant trastuzumab/ pertuzumab-containing therapy. Pathologic response correlated inversely with HER2/CEP17 ratio and HER2 copy number. Reassessment of HER2 expression with more sensitive quantitative methods, particularly in IHC 2+/FISH+ tumors, may improve therapeutic stratification."

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

ECONOMIC EVALUATION OF FIXED-DOSE SUBCUTANEOUS PERTUZUMAB-TRASTUZUMAB FOR NEOADJUVANT TREATMENT OF HIGH-RISK HER2-POSITIVE EARLY BREAST CANCER IN INDONESIA (ISPOR 2026) - "In the Indonesian setting, pertuzumab plus trastuzumab administered subcutaneously in combination with chemotherapy considered cost effective compared to chemotherapy alone. The intervention appears most economically advantageous for women diagnosed at age 35."

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

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=596 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

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

Neoadjuvant twelve weekly paclitaxel-carboplatin with trastuzumab and pertuzumab in HER2-positive breast cancer. (PubMed, Breast Cancer Res Treat) - "In this retrospective cohort study, neoadjuvant 12wTCHP was well tolerated and associated with high pCR and low early recurrence rates. These findings are hypothesis-generating and support further evaluation of de-escalated 12wTCHP regimen in selected patients."

Journal • Retrospective data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • ER • HER-2

ADEPT: A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (clinicaltrials.gov) - P2 | N=393 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2026 ➔ Mar 2026

Enrollment closed • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Adjuvant pertuzumab + trastuzumab vs trastuzumab monotherapy after pCR in early stage HER2-positive breast cancer (HOPA 2026) - "Adult patients were included if they had early stage high-risk HER2-positive breast cancer patients (T2 and/or N1), received neoadjuvant pertuzumab, trastuzumab, carboplatin and docetaxel (PTCH) therapy and had pCR (pathologic stage "ypT0/Tis ypN0") at the time of definitive surgery 1/1/2017 - 9/30/2025, aged 18 years or older, received at least four cycles/doses of pertuzumab in neoadjuvant setting, and had their surgery completed at OSU. This study aims to assess the impact of dual-HER2 directed therapy vs. trastuzumab alone in the adjuvant setting has an effect on cancer-related outcomes. Study findings could result in optimized application of adjuvant treatment regimens."

Clinical • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Increasing Outpatient Infusion Efficiency with Subcutaneous Formulations (HOPA 2026) - "Background Daratumumab/hyaluronidase and pertuzumab/trastuzumab/hyaluronidase are non-hazardous chemotherapy drugs used for various cancers and conditions. The daratumumab/hyaluronidase study group did not yield a difference in time since the drug is used in combination with other drugs and pre-medications. The nursing preparation model offered a decrease in both preparation and administration costs with a combined savings of $2,787."

Clinical

Anthracycline-Free Neoadjuvant Pertuzumab-Trastuzumab-Taxane in Patients with HER2-Positive Early Breast Cancer: Hormone Receptor Status as a Key Determinant of Pathological Complete Response. (PubMed, Biomedicines) - " Anthracycline-free THP is a highly active, well-tolerated neoadjuvant option for HER2-positive EBC, with particularly high pCR rates in HR-negative disease. HR status emerged as a key determinant of pCR, whereas the role of PIK3CA mutations remains inconclusive and requires confirmation in larger prospective studies."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Clinical Significance of Achieving No Evidence of Disease in HER2-Positive Metastatic Breast Cancer: A Multicenter Study by Turkish Oncology Group (TOG). (PubMed, Cancers (Basel)) - "Metastasis-directed local therapy and treatment regimen (trastuzumab vs. trastuzumab + pertuzumab) were not independently associated with NED attainment or PFS...Radiologic NED was independently associated with prolonged PFS within this enriched population. Factors associated with NED attainment included favorable ECOG performance status, HER2 IHC 3+ expression, and high tumor grade; given the wide confidence intervals, these estimates should be interpreted cautiously as exploratory and hypothesis-generating."

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

Overcoming Trastuzumab-Pertuzumab Resistance and Optimizing Sequential Anti-HER2 Therapy in HER2-Positive Metastatic Breast Cancer. (PubMed, Cancers (Basel)) - "Trastuzumab deruxtecan demonstrates substantial antitumor activity through potent cytotoxic effects and a bystander effect, supporting its efficacy in tumors with intratumoral heterogeneity or downstream pathway activation. In contrast, tucatinib-based regimens represent an important option for patients with brain metastases and tumors expressing p95HER2. The ongoing development of novel antibody-drug conjugates and bispecific antibodies is expected to further advance personalized sequential therapy targeting composite resistance mechanisms."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3

Hormone Receptor Status as a Predictive Factor for Pathological Complete Response to Neoadjuvant Dual HER2 Blockade in Patients with HER2-Positive Breast Cancer: A Multicenter Retrospective Study. (PubMed, Breast Care (Basel)) - "Neoadjuvant therapy with dual human epidermal growth factor receptor 2 (HER2) blockade using trastuzumab and pertuzumab combined with chemotherapy is the standard of care for patients with locally advanced HER2-positive breast cancer...HR status is a strong and independent predictor of pCR in HER2-positive breast cancer patients receiving neoadjuvant dual blockade. Patients with HR- disease derive the most benefit from this regimen, highlighting the need for tailored therapeutic strategies to improve outcomes for the HR+ subgroup."

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

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=1800 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

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