Herceptin (trastuzumab)

P2/3, N=82, Completed, MacroGenics | Active, not recruiting --> Completed

P1, N=198, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2024 --> Dec 2025

[68Ga]Ga-NODAGA-ADAPT6 exhibited excellent pharmacokinetic properties and high specificity for HER2-expressing lesions in PET imaging. These findings highlight its potential as a promising tool for distinguishing different levels of HER2 expression in breast cancer, aiding in personalized treatment strategies.

Comprehensive cardiac monitoring before, during, and after anthracycline and trastuzumab regimens is essential. Tailored assessments can help identify vulnerable patients, optimize treatment, and mitigate risks of heart complications while maintaining therapy efficacy.

P2, N=49, Recruiting, Memorial Sloan Kettering Cancer Center | N=25 --> 49

P3, N=864, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=2175, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Recruiting --> Active, not recruiting

The findings support the exploration of a prospective personalized risk-based approach to cardiac LVEF surveillance during trastuzumab therapy. Less frequent LVEF monitoring in low-risk patients may optimize resource use and reduce patient burden without compromising safety.

Trastuzumab or trastuzumab plus pertuzumab significantly improved TpCR rates and DFS in HER2(3+)/HoR- and HER2(3+)/HoR+ but not in HER2(2+)/HoR- and HER2(2+)/HoR+. Cohort 2 showed significant PAM50 subtype differences across these groups (p<0.001). In conclusion, the responsiveness of HER2-positive breast cancer to neoadjuvant targeted therapy is significantly influenced by HER2 expression levels and HoR status, emphasizing the necessity of precision medicine approaches to tailor therapeutic strategies for improved clinical outcomes.

In this randomized clinical trial, add-on atezolizumab to trastuzumab plus XELOX therapy demonstrated promising efficacy in this patient population, and no new safety concerns were raised. ClinicalTrials.gov Identifier: NCT04661150.

Immunofluorescence findings suggest that C3 recruits complement receptor 2 to enhance trastuzumab efficacy in HER2+ patients. This finding highlights the potential of complement 3 to improve therapeutic outcomes and pave the way for more personalized treatment strategies in BC.

P2, N=178, Active, not recruiting, Fudan University | Unknown status --> Active, not recruiting | Trial completion date: May 2021 --> Jun 2027 | Trial primary completion date: May 2021 --> Jul 2025

ICIs combined with standard treatment regimens for patients with advanced HER-2-positive gastric cancer demonstrate favorable clinical efficacy, significantly prolonging PFS with manageable safety. ECOG performance status, peritoneal metastasis, positive PD-L1 expression, and treatment regimen are independent factors influencing PFS, warranting increased clinical attention to patients exhibiting these factors.

P=N/A, N=300, Not yet recruiting, Women's College Hospital

P2, N=180, Not yet recruiting, Henan Cancer Hospital

Both paclitaxel and docetaxel are effective in neoadjuvant dual HER2 blockade regimens. Paclitaxel demonstrated better DFS, OS, and a favorable safety profile, supporting its use as a preferred option.

P3, N=504, Not yet recruiting, BioNTech SE | Trial completion date: Aug 2029 --> Jan 2030 | Trial primary completion date: Oct 2027 --> Mar 2028

P2, N=130, Recruiting, Population Health Research Institute | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Dec 2025

Diagnosed as splenic metastasis post-gastric cancer surgery, she underwent chemotherapy with S-1, cisplatin, and trastuzumab...The final pathology revealed an inflammatory pseudotumor of the spleen, and the patient is under observation. This case highlights successful management of a splenic tumor following distal gastrectomy with preservation of the remnant stomach using laparoscopic splenectomy and intraoperative ICG fluorescence imaging.

Neoadjuvant chemotherapy with paclitaxel, trastuzumab and pertuzumab was started. There are no signs of recurrence of breast cancer and pulmonary tuberculosis for 5 years. Chemotherapy for breast cancer and premedication with corticosteroid may have inhibited cellular immunity, causing endogenous relapse of tuberculosis.

Rarely, antibodies directed against human epidermal growth factor receptor 2 (HER-2), such as trastuzumab, may trigger dermatomyositis, and immune checkpoint inhibitors may incite the Wong variant of dermatomyositis, characterised by clinical and histopathologic features of pityriasis rubra pilaris, including monomorphic keratotic papules. We present an unusual case of dermatomyositis with features of the Wong variant occurring in a 51-year-old female with a history of breast cancer after completion of adjuvant therapy with trastuzumab.

P1/2, N=150, Recruiting, FBD Biologics Limited | Not yet recruiting --> Recruiting

Neoadjuvant camrelizumab plus trastuzumab and chemotherapy demonstrated favorable response and tolerable safety in HER2-positive G/GEJ adenocarcinoma.

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.

P2, N=72, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting

The ExteNET study showed that 1 year of extended adjuvant neratinib after trastuzumab-based adjuvant therapy could reduce invasive disease-free survival (iDFS) events compared with placebo...After enrollment, patients received 1 year of extended adjuvant pyrotinib (400 mg/day), which should be initiated within 6 months after the completion of 1-year adjuvant therapy (trastuzumab alone or plus pertuzumab)...No external funding was received for this work. ClinicalTrials.gov: NCT05880927.

The comprehensive analytical characterization confirms the biosimilarity of Tuznue® to Herceptin®. This supports Tuznue® as a safe and effective alternative, offering a more affordable option for patients and healthcare systems. Biosimilar development requires overcoming inherent challenges, particularly when reference products exhibit variability in quality attributes over time. Regulatory guidance and scientific rigor are essential to ensuring biosimilar similarity, facilitating broader patient access to life-saving therapies.

We collected patient-level data from the HERceptin Adjuvant (HERA) (BIG1-01; ClinicalTrials.gov identifier: NCT00045032) trial...CTS5 is a useful prognostic tool for predicting late DR and OS in HR-positive, HER2-positive breast cancer patients. Extension of endocrine therapy should be actively considered in patients with CTS5 high-risk group.

P=N/A, N=60, Not yet recruiting, Gansu Provincial Cancer Hospital; Gansu Provincial Cancer Hospital

P4, N=161, Not yet recruiting, Xiangya Hospital, Central South University; Xiangya Hospital, Central South University

The current study suggests that even minimal residual tumor cells in the primary site can significantly impact on prognosis in HER2-positive early breast cancer.

Interruption of trastuzumab treatment was associated with an increase in overall survival time compared with continued treatment (22.5 months; 95% CI: 21.8 - 23.3 vs. 17.7 months; 95% CI: 15.9 - 19.4; P = 0.001). The adjusted risk model revealed that continued trastuzumab therapy was independently associated with a 2.86-fold increased risk of mortality.

P4, N=200, Not yet recruiting, Henan Provincial People's Hospital; Henan Provincial People's Hospital

P3, N=920, Active, not recruiting, Jazz Pharmaceuticals | Recruiting --> Active, not recruiting

Many HER2-positive breast cancer (BC) patients relapse within a year of trastuzumab or neratinib treatment. This study identifies new hotspot mutations in HER2 domains II and IV causing trastuzumab resistance. Notably, cells with either wild-type or the examined dimerization domain mutations retained sensitivity to the FDA-approved HER2 kinase inhibitor, tucatinib.

P2, N=13, Active, not recruiting, Spanish Breast Cancer Research Group | Recruiting --> Active, not recruiting | N=49 --> 13

Therefore, HER2/neu can be a predictive and therapeutic marker in colorectal cancers. This underscores the potential importance of incorporating these parameters in the clinical evaluation and targeted treatment strategies for CRC patients.

Clinical trials investigating mTOR inhibitors like sirolimus and combination therapies with agents such as everolimus and trastuzumab are discussed, underscoring their potential in eradicating BCSCs and improving patient outcomes. In conclusion, targeting the mTOR pathway presents a viable and promising avenue for enhancing breast cancer treatment efficacy by effectively eliminating BCSCs, reducing tumor recurrence, and improving overall patient survival. Continued research and clinical validation of mTOR-targeted therapies are essential to translate these insights into effective clinical interventions, ultimately advancing personalized cancer management and therapeutic outcomes for breast cancer patients.

Hemorrhagic cystitis is a rare complication of combination chemotherapy with docetaxel (TCHP). Clinicians should be vigilant for signs and symptoms of hemorrhagic cystitis in patients receiving docetaxel and alternative treatment option should be considered.

As a proof of concept, we synthesized an HER2-targeting trastuzumab immunoconjugate bearing a NIR-II aza-BODIPY fluorophore...The resulting Trastu-azaNIRII-MMAE selectively accumulated in HER2-positive subcutaneous tumors, significantly reducing the tumor growth. Using NIR-II optical imaging, a single injection of the NIR-II-ADC allowed for the detection of the conjugate over a period of more than one month, highlighting its potential for long-term tracking and therapeutic applications.

For metastatic SCC in the first-line, nivolumab combined with chemotherapy or with ipilimumab (TPS (tumor proportion score) ≥1 %, SCC, CHECKMATE 648) are approved, as well as second-line nivolumab alone regardless of PD-L1 status (ATTRACTION 03). For both, locally advanced or metastatic SCC and EGC, chemotherapy with pembrolizumab is available for patients with CPS (combined positive score) ≥10 (KEYNOTE 590) and for adenocarcinoma with nivolumab (CPS ≥5, CHECKMATE 649). Recent added approvals are chemotherapy with pembrolizumab in CPS ≥1 patients (KEYNOTE 859) and the addition of trastuzumab for personalized therapy in HER-2 positive/CPS ≥1 gastric and GEJ patients (KEYNOTE 811).