ER-positive breast cancer is a hormone receptor-positive subtype in which tumor cells express estrogen receptor and can depend on estrogen signaling for growth. This biology guides treatment toward endocrine-based therapies and affects prognosis. It is a major subtype within invasive breast carcinomas.
Roche's experimental breast cancer pill giredestrant combined with a CDK4/6 inhibitor failed to meet its primary endpoint in a Phase III trial for first-line treatment of ER-positive, HER2-negative advanced breast cancer, marking a setback for the drugmaker's next-generation hormone therapy program.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
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.
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07482384 |
Supporting Health Including Endocrine Treatment for Long Duration |
NOT_YET_RECRUITING | NA |
| NCT07085767 |
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT07038369 |
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06176261 |
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs |
RECRUITING | PHASE2 |
| NCT06016738 |
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT05868226 |
PRE-I-SPY Phase I/Ib Oncology Platform Program |
RECRUITING | PHASE1 |
| NCT05720260 |
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC |
RECRUITING | PHASE2 |
| NCT05396612 |
Role of the Immune Environment in Response to Therapy in Breast Cancer |
RECRUITING | |
| NCT05101564 |
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer |
COMPLETED | PHASE2 |
| NCT04901299 |
Fulvestrant + Neratinib In Breast Cancer |
WITHDRAWN | PHASE2 |
