- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal: Multimodality Imaging Review of HER2-positive Breast Cancer and Response to Neoadjuvant Chemotherapy. (Pubmed Central) - Jan 13, 2023 The authors review the initial manifestations of HER2-positive tumors, the varied responses to neoadjuvant chemotherapy, and the challenges in assessing residual cancer burden through a multimodality imaging review with pathologic correlation. RSNA, 2023 Quiz questions for this article are available through the Online Learning Center.
- |||||||||| Trial completion date, Trial primary completion date, Tumor mutational burden, Pan tumor: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (clinicaltrials.gov) - Jan 11, 2023
P2, N=720, Recruiting, These analyses confirm the role of HER2 tumor biology and the immune microenvironment in influencing pCR in the neoadjuvant setting and reaffirm the molecular diversity of HER2-positive breast cancer. Trial completion date: Sep 2023 --> Jan 2027 | Trial primary completion date: Jun 2023 --> Jan 2026
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial primary completion date, Surgery, Metastases: 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) - Jan 10, 2023 P2, N=240, Active, not recruiting, Trial completion date: Sep 2023 --> Jan 2027 | Trial primary completion date: Jun 2023 --> Jan 2026 Trial primary completion date: Nov 2023 --> Nov 2022
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Review, Journal, Metastases: Systemic Therapy for HER2-Positive Metastatic Breast Cancer: Current and Future Trends. (Pubmed Central) - Jan 9, 2023 The standard of care was dual blockade with trastuzumab and pertuzumab as first-line followed by TDM-1 as second-line...Notably, the development of new-generation ADCs has led to unprecedented results compared with T-DM1, currently establishing trastuzumab deruxtecan as a new standard of care in second-line...Response rate and overall life expectancy decrease with each additional line of treatment, and tumor heterogeneity remains an issue. In this review, we update the new-targeted therapeutic options for HER2-positive BC and highlight the future perspectives of treatment in this setting.
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal: Molecular Basis of HER2-Targeted Therapy for HER2-Positive Colorectal Cancer. (Pubmed Central) - Jan 9, 2023 To improve the therapeutic efficacy of the current strategy, many clinical trials with various HER2-targeted agents are ongoing. This review discusses the molecular basis of HER2-targeted therapeutic strategies for patients with HER2-positive mCRC.
- |||||||||| Enrollment open, Trial completion date, Trial primary completion date: RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer (clinicaltrials.gov) - Jan 9, 2023
P1/2, N=48, Recruiting, (4) A combination of LVEF, NT-proBNP and ST2/IL-33R assessment may be useful for early detection of cardiac impairment in breast cancer patients treated with trastuzumab, pertuzumab and docetaxel. Not yet recruiting --> Recruiting | Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal: Focusing on NK cells and ADCC: A promising immunotherapy approach in targeted therapy for HER2-positive breast cancer. (Pubmed Central) - Jan 6, 2023 In this review, we provide an overview of the role of natural killer (NK) cells and ADCC in targeted therapy of HER2-positive breast cancer, including the biological functions of NK cells and the role of NK cells and ADCC in anti-HER2 targeted drugs. We then discuss regulatory mechanisms and recent strategies to leverage our knowledge of NK cells and ADCC as an immunotherapy approach for HER2-positive breast cancer.
- |||||||||| Trial completion date, Trial primary completion date, Tumor mutational burden: CRAFT: The NCT-PMO-1602 Phase II Trial (clinicaltrials.gov) - Jan 4, 2023
P2, N=175, Recruiting, We then discuss regulatory mechanisms and recent strategies to leverage our knowledge of NK cells and ADCC as an immunotherapy approach for HER2-positive breast cancer. Trial completion date: Apr 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Jun 2025
- |||||||||| Irene (pyrotinib) / Jiangsu Hengrui Pharma
Review, Journal: Clinical updates on tyrosine kinase inhibitors in HER2-positive breast cancer. (Pubmed Central) - Dec 30, 2022 The antibody-drug conjugates adotrastuzumab, emtansine, famtrastuzumab, and deruxtecan, as well as the anti-HER2 monoclonal antibody pertuzumab are used in both early-stage and metastatic situations, either alone or in conjunction with chemotherapy and other HER2-targeting therapies...Anti-HER2 ligands can be used in various nano formulations to target HER2 receptors. Here we will discuss, targeted TKIs in patients with HER2+ BC, clinical studies of HER2+ targeted TKIs, mechanisms of resistance to HER2-directed therapies with new implications of TKIs in HER2+ MBC (metastatic breast cancer) and anti-HER2 ligand in various nano formulations to target HER2 receptors.
- |||||||||| Perjeta (pertuzumab) / Roche
Journal: Access to Neoadjuvant Pertuzumab for HER2 Positive Breast Cancer in Canada: A Dilemma Increasingly Difficult to Explain. (Pubmed Central) - Dec 23, 2022 We discuss the implications for Canadian patients with HER2+ early breast cancer due to a second and final negative funding decision by the Canadian Agency for Drugs and Technologies in Health (CADTH) related to neoadjuvant pertuzumab. This decision will have adverse impacts for up to 1 in 6 women receiving neoadjuvant therapy for high-risk HER2+ breast cancer, due to suboptimal pCR rates and higher risks of invasive breast cancer recurrent events, resulting in the need for more toxic adjuvant therapy.
- |||||||||| Trial completion date, Trial primary completion date, Tumor mutational burden, Metastases: My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Dec 21, 2022
P2a, N=670, Active, not recruiting, Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile. Trial completion date: Jan 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023
- |||||||||| Piqray (alpelisib) / Novartis
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: 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) - Dec 19, 2022 P3, N=19, Active, not recruiting, Patients in the trastuzumab+pertuzumab group had a higher pCR rate than those in the trastuzumab group, and the toxic side effects were tolerable. Recruiting --> Active, not recruiting | N=511 --> 19 | Trial completion date: Jul 2031 --> Apr 2024 | Trial primary completion date: Jun 2025 --> Apr 2024
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal: Association of Endocrine Therapy for HR+/ERBB2+ Metastatic Breast Cancer With Survival Outcomes. (Pubmed Central) - Dec 16, 2022 Using the time-dependent ET variable among patients with ERBB2-targeted therapy with CT, those with maintenance ET had significantly better PFS (hazard ratio, 0.70; 95% CI, 0.60-0.82; P < .001) and OS (hazard ratio, 0.47; 95% CI, 0.39-0.57; P < .001). These results suggest that ET-containing first-line regimens may be associated with benefits among a subgroup of patients with HR+/ERBB2+ MBC.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date, Surgery, Metastases: 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) - Dec 7, 2022 P2, N=240, Active, not recruiting, Larger prospective studies are needed to validate the HER2 ratio as a biomarker to select patients for neoadjuvant dual anti-HER2 therapy without chemotherapy. Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Nov 2022 --> Nov 2023
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Clinical, P3 data, Journal: Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study. (Pubmed Central) - Dec 5, 2022 P3 Safety remained consistent with the known pertuzumab profile. Overall, PUFFIN contributes to the totality of data with pertuzumab in previously untreated HER2-positive locally recurrent or metastatic breast cancer and supports the favorable benefit-risk profile of pertuzumab in Chinese patients.
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