August 31st 2023
Combining tucatinib with ado-trastuzumab emtansine does not appear to result in any new safety signals in the treatment of those with locally advanced or metastatic HER2-positive breast cancer.
July 15th 2023
Findings from the phase 3 DESTINY-Breast04 trial supported the approval of fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer in China.
May 22nd 2023
Hospitalization rates appear to be comparable between patients receiving trastuzumab deruxtecan and trastuzumab emtansine for HER2-positive breast cancer in the phase 3 DESTINY-Breast03 study.
May 17th 2023
Investigators identify several potential first time risk factors of long-term outcomes in patients with HER2-positive breast cancer with or without a pathologic complete response.
May 16th 2023
The FDA requests additional information requiring time and resources extending beyond the current evaluation period for vic-trastuzumab duocarmazine in advanced HER2-positive breast cancer.
FDA Accepts BLA for Trastuzumab Biosimilar HLX02 in HER2+ Cancers
Supporting data for the biologics license application for trastuzumab biosimilar HLX02 in HER2-overexpressing cancers come from comparative analytical studies and a global phase 3 trial.
Novel Antibody-Drug Conjugate Yields PFS Benefit in HER2+ Breast Cancer
Investigators plan to submit a communication application to seek marketing approval in China for ARX788 as therapy for HER2-positive advanced or metastatic breast cancer.
Trastuzumab Deruxtecan Receives Chinese Approval in HER2+ Breast Cancer
Adult patients with previously treated unresectable or metastatic HER2-positive breast cancer in China can now receive treatment with trastuzumab deruxtecan.
Recap: Treating Patients With HER2+ Metastatic Breast Cancer: Insights From Experts at Dana- Farber Cancer Institute
Based on several patient cases, expert oncologists review the evolving treatment landscape of HER2+ breast cancer with a focus on brain metastases.
Recap: HER2+ Breast Cancer and Brain Metastases: Challenges and Treatments
Breast cancer experts discuss the latest research into the treatment of HER2+ metastatic breast cancer with brain metastases and how new data may affect decision-making in 3 patient cases.
Image-Guided Vacuum Core Biopsy May Identify CR in HER2+ Breast Cancer and TNBC Following Neoadjuvant Therapy
Patients with HER2-positive breast cancer and triple-negative breast cancer may not require breast surgery if a pathological complete response can be identified using image-guided vacuum core biopsy following neoadjuvant systemic therapy.
EU’s CHMP Recommends Fam-Trastuzumab Deruxtecan-nxki for Approval in HER2-Low Breast Cancer
Fam-trastuzumab deruxtecan-nxki has been recommended for approval by the European Union’s Committee for Medicinal Products for Human Use in patients with HER2-low advanced breast cancer.
Real-World Analysis of Tucatinib Triplet Yields Positive Safety Profile in HER2+ Metastatic Breast Cancer
Results from the real-world analysis of the phase 2 HER2CLIMB trial showed a good safety profile with the tucatinib triplet regimen in patients with HER2-positive metastatic breast cancer.
Eribulin Yields Similar Benefit to Standard Chemotherapeutics for HER2-low and HER2-0 Metastatic Breast Cancer
Patients with HER2-low or HER2-0 metastatic breast cancer who previously received at least 1 chemotherapy agent garnered similar benefit from eribulin mesylate vs standard physician's choice chemotherapies.
With Longer Follow-Up, Trastuzumab Deruxtecan Improves Survival vs T-DM1 in HER2+ Metastatic Breast Cancer
Trastuzumab deruxtecan improved survival outcomes vs trastuzumab emtasine in patients with HER2-positive breast cancer, according to updated results from the DESTINY-Breast03 trial.
Case Presentation: A 69-Year-Old Woman with HER2+ Metastatic Breast Cancer (mBC)
Heather McArthur, MD, presents the case of a 69-year-old woman with stage II HER2+ mBC for discussion.
Trastuzumab Deruxtecan Improves Survival in HER-2 Positive Breast Cancer Compared to Capecitabine Regimens
Patients with advanced HER2-positive breast cancer had improved progression-free and overall survival when treated with trastuzumab deruxtecan compared with capecitabin-based treatment, according to recent findings.
Sara Hurvitz, MD, Discusses The HER2-Low Breast Cancer Landscape Following 2022 ASCO, Cites Need for Future Investigation
According to Hurvitz, the findings of trials such as DESTINY-Breast04 and TROPiCS-02 shed light on potential new therapies for breast cancer, though more research is needed to address new agents and other unmet needs.
TAC01-HER2 Cell Therapy Demonstrates Promising Clinical Activity in HER2+ Solid Tumors
Interim data from the phase 1/2 TACTIC-2 trial indicated that treatment with TAC01-HER2 cell therapy produced a 67% disease control rate among a cohort of patients with HER2-positive solid tumors.
PFS Benefit Observed Following Capivasertib/Fulvestrant in HR+ HER2-Low Locally Advanced Breast Cancer
The addition of capivasertib to fulvestrant resulted in a statistically significant and clinically meaningful improvement in progression-free survival for patients with hormone receptor–positive, HER2-low-or -negative locally advanced or metastatic breast cancer.
Neoadjuvant Pegylated Lipsomal Doxorubicin/Cyclophosphamide Plus Trastuzumab/Pertuzumab Yields Promising Efficacy in HER2+ Breast Cancer
Findings from a phase 2 clinical study indicated that neoadjuvant pegylated liposomal doxorubicin plus cyclophosphamide, trastuzumab, and pertuzumab demonstrated promising efficacy and safety in the treatment of HER2-positive breast cancer.
Recap: Treatment Options for Patients With HER2-Positive Breast Cancer and Brain Metastases
A panel of experts in breast oncology builds a lively discussion on evolving approaches in the management of HER2+ metastatic breast cancer, including key considerations for the treatment of patients with brain metastases.
Significant Improvement in PFS Observed With T-DXd Vs Physician’s Choice of Therapy in HER2+ Advanced Breast Cancer
The primary end point of improved progression-free survival was met in the phase 3 DESTINY-Breast02 trial when patients with HER2-positive unresectable and/or metastatic breast cancer were given trastuzumab deruxtecan vs physician’s choice of therapy.
FDA Approves Trastuzumab Deruxtecan in Unresectable or Metastatic HER2-Low Breast Cancer
Based on results from the phase 3 DESTINY-Breast04 trial, the FDA has approved fam-trastuzumab deruxtecan-nxki as an intravenous infusion for patients with unresectable or metastatic HER2-low breast cancer.
FDA Grants Priority Review to T-DXd for Advanced HER2-Low Metastatic Breast Cancer
Trastuzumab deruxtecan was granted priority review by the FDA for patients with unresectable advanced or metastatic HER2-low breast cancer.
Trastuzumab Deruxtecan Receives EU Approval for Previously Treated Unresectable/Metastatic HER2+ Breast Cancer
European patients with unresectable or metastatic HER2-positive breast cancer are now able to receive treatment with trastuzumab deruxtecan following 1 or more previous anti-HER2 regimens.
Long-Term Follow-Up Indicates Adjuvant Pertuzumab, Trastuzumab, and Chemo Reduces Recurrence in HER2+ Early Breast Cancer
Long-term follow-up data continue to show that patients with lymph node–positive, HER2-positive early breast cancer at a high risk of recurrence derived notable, durable benefit from treatment with adjuvant pertuzumab, trastuzumab, and chemotherapy.
Recap: Updates in Treatment of HER2-Positive Breast Cancer and Brain Metastases
Sara A. Hurvitz, MD; Stefania Maraka, MD; and Ruta Rao, MD, discuss the evolving landscape of metastatic HER2+ breast cancer, highlighting recent clinical trials and the management of patients with brain metastases.
FDA Lifts Clinical Hold on Phase 3 Trial Assessing GLSI-100 in Patients With HER2/Neu-Positive Breast Cancer and HLA-A*02
The FDA has allowed the phase 3 FLAMINGO-01 trial assessing GLSI-100 in patients with HER2/Neu-positive breast cancer and HLA-A*02 positive to proceed following concerns related to the manufacturing and pharmacy process.
Biologics License Application Accepted for Vic-Trastuzumab Duocarmazine in HER2+ Advanced Breast Cancer
The FDA has accepted a biologics license application for vic-trastuzumab duocarmazine for patients with HER2-positive unresectable locally advanced or metastatic breast cancer.
Supplemental New Drug Application Submitted in Japan for Trastuzumab Deruxtecan in HER2-Low Breast Cancer
Patients with HER2-low unresectable or recurrent breast cancer in Japan could receive treatment with trastuzumab deruxtecan in the future if the newly submitted supplemental new drug application for this indication is approved.
European Medicines Agency Recommends T-DXd for Approval in European Union in Advanced HER2+ Breast Cancer
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended for approval trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive breast cancer.
De-Escalation Trastuzumab/Pertuzumab ± Paclitaxel Yields Promising Responses in HER2+/HR– Early Breast Cancer
Results from the WSG-ADAPT-HER2+/HR- study showed promising survival rates with pathological complete response when patients with HER2-positive, hormone receptor-negative early breast cancer were treated with a de-escalated dose of trastuzumab plus pertuzumab without or without paclitaxel over a 12-week period.
Tucatinib To Be Examined as Add-On to First-Line Maintenance in HER2+ Metastatic Breast Cancer
The phase 3 HER2CLIMB-05 trial will investigate tucatinib plus standard of care maintenance in the first-line setting for patients with HER2-positive metastatic breast cancer.
Trastuzumab Deruxtecan Use for Metastatic HER2+ Breast Cancer Validated at Safety Analysis
An acceptable safety reported at a follow-up analysis of the phase 3 DESTINY-Breast03 study has reinforced use of fam-trastuzumab deruxtecan-nxki for patients with HER2-positive unresectable or metastatic breast cancer
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