HER2-positive metastatic breast cancer is advanced breast cancer with distant spread and HER2 overexpression/amplification. This subtype tends to be biologically aggressive but can respond to HER2-targeted systemic therapies that have improved outcomes. Treatment usually involves sequential targeted regimens combined with chemotherapy or endocrine therapy depending on receptor profile.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07503717 |
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance |
RECRUITING | NA |
| NCT06714617 |
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06625775 |
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT06595563 |
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer |
RECRUITING | PHASE2 |
| NCT06551116 |
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer |
RECRUITING | |
| NCT06305702 |
Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer |
COMPLETED | |
| NCT06299852 |
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer |
RECRUITING | NA |
| NCT06298084 |
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd |
RECRUITING | PHASE1/PHASE2 |
| NCT06278870 |
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial |
RECRUITING | PHASE3 |
| NCT05959291 |
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer |
RECRUITING | NA |
