HER2-negative breast cancer is breast cancer without HER2 overexpression/amplification and therefore does not respond to HER2-targeted therapies used for HER2-positive disease. It includes several biologic subgroups such as hormone receptor-positive/HER2-negative and triple-negative tumors. Treatment depends on hormone receptor status, stage, and other molecular features.
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
Whole genome sequencing, comprehensive genomic profiling, and spatial multiomics are transforming precision medicine from research tools to clinical applications in oncology, rare diseases, and neonatal care, enabling faster diagnoses and personalized treatments.
The FDA has granted fast track designation to ART6043 plus olaparib for germline BRCA-mutated HER2-negative breast cancer and to BriaCell's Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer, both addressing significant unmet medical needs.
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602907 |
Metronomic Oral Paclitaxel Monotherapy and Combined Immunotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose Exploration and Expansion Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07483307 |
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer |
RECRUITING | PHASE2 |
| NCT07466927 |
Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07396454 |
Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib |
RECRUITING | PHASE2 |
| NCT07379918 |
Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer |
RECRUITING | |
| NCT07366112 |
CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment |
NOT_YET_RECRUITING | PHASE2 |
| NCT07281833 |
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment |
RECRUITING | PHASE3 |
| NCT07227831 |
A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer |
NOT_YET_RECRUITING | NA |
| NCT07218432 |
A Study of the TheraBionic P1 Device in Breast Cancer |
RECRUITING | NA |
| NCT07198724 |
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer |
RECRUITING | PHASE1/PHASE2 |
