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.
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 |
|---|---|---|---|
| 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 |
| NCT07600164 |
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer |
NOT_YET_RECRUITING | PHASE4 |
| NCT07597629 |
A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07591090 |
A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07560475 |
Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients |
NOT_YET_RECRUITING | PHASE2 |
| NCT07540533 |
A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer |
RECRUITING | PHASE2 |
| NCT07524322 |
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT07428655 |
Acceptability and Feasibility of PSC Model of Serious Illness Communication |
ACTIVE_NOT_RECRUITING | NA |
| NCT07427394 |
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07408089 |
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer |
RECRUITING | PHASE1 |
