Advanced breast cancer commonly refers to metastatic (stage IV) breast cancer, where tumor cells have spread beyond the breast and regional lymph nodes to distant organs such as bone, liver, lung, or brain. It may present at initial diagnosis or appear after earlier-stage treatment.
Relay Therapeutics reported Q4/FY 2025 results, outlined 2026 milestones for zovegalisib, and held ~$555M in cash. Initial vascular anomaly data and breast cancer triplet data are expected in 2026.
Roche's giredestrant plus palbociclib missed its primary endpoint in a phase 3 breast cancer trial. Numerical improvement was seen without statistical significance. Shares fell sharply; a second readout is due in 2027.
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.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
The SONIA trial found no overall survival benefit for first-line CDK4/6 inhibitors versus second-line use in advanced HR+/HER2- breast cancer. Median survival was 47.9 vs 48.1 months, though post hoc analysis suggested benefit in premenopausal patients. First-line treatment was associated with more severe adverse events.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
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.
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
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.
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07766772 |
Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07701070 |
SHIELD: Surveillance of HR+/HER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC |
NOT_YET_RECRUITING | |
| NCT07684456 |
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07683754 |
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd |
NOT_YET_RECRUITING | PHASE3 |
| NCT07681323 |
Timing of ctDNA Testing in Advanced Breast Cancer |
RECRUITING | |
| NCT07635147 |
Decision Support Tool for Patients With Advanced Breast Cancer |
RECRUITING | NA |
| NCT07630103 |
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07619365 |
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07619066 |
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07602907 |
Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study |
RECRUITING | PHASE2 |
