ER+/HER2- breast cancer is a hormone receptor-positive, HER2-negative molecular subtype of breast cancer, usually corresponding to luminal biology. This subtype is typically managed with endocrine-based therapy and has different prognosis and treatment patterns from HER2-positive and triple-negative disease. It is the most common breast cancer subtype in population datasets.
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
CDK4/6 inhibitors have transformed HR+/HER2− breast cancer treatment, while emerging resistance mechanisms are driving development of selective CDK2 inhibitors and dual CDK2/4 strategies to address treatment failure.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06964906 |
Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter) |
RECRUITING | PHASE2 |
| NCT06064812 |
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC. |
RECRUITING | PHASE1/PHASE2 |
