Also known as: HR+/HER2- breast cancer
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
Novartis will acquire Pikavation Therapeutics for up to $3 billion to gain its PI3Kα inhibitor programs, led by SNV4818 for metastatic breast cancer. The deal includes $2 billion upfront and up to $1 billion in milestones, with completion expected in first half 2026. SNV4818 is designed to selectively target mutated PI3Kα while sparing healthy cells.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07702708 |
Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+/HER2- Breast Cancer |
RECRUITING | |
| NCT07691333 |
Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07492641 |
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease |
RECRUITING | PHASE3 |
| NCT07242352 |
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC |
RECRUITING | PHASE3 |
| NCT07106632 |
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests |
RECRUITING | PHASE3 |
| NCT06998407 |
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT06860529 |
Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer |
RECRUITING | PHASE2 |
