HER2-Positive Breast Cancer

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.

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.

Adult patients with previously treated unresectable or metastatic HER2-positive breast cancer in China can now receive treatment with trastuzumab deruxtecan.

Based on several patient cases, expert oncologists review the evolving treatment landscape of HER2+ breast cancer with a focus on brain metastases.

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.

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.

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.

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.

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.

Trastuzumab deruxtecan improved survival outcomes vs trastuzumab emtasine in patients with HER2-positive breast cancer, according to updated results from the DESTINY-Breast03 trial.

Heather McArthur, MD, presents the case of a 69-year-old woman with stage II HER2+ mBC for discussion.

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.

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.

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.

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.

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.

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.

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.

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.

Trastuzumab deruxtecan was granted priority review by the FDA for patients with unresectable advanced or metastatic HER2-low 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 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.

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.

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.

The FDA has accepted a biologics license application for vic-trastuzumab duocarmazine for patients with HER2-positive unresectable locally advanced or metastatic 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.

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.

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.

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.

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