Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
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.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
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.
Recent studies examine self-management strategies for breast cancer treatment-related cardiotoxicity and highlight risks of vertebral fractures after discontinuing denosumab therapy in patients receiving aromatase inhibitors.
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 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 |
|---|---|---|---|
| NCT07400523 |
Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy |
RECRUITING | PHASE3 |
| NCT07222267 |
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT06495164 |
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer |
ACTIVE_NOT_RECRUITING | |
| NCT06440967 |
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06218303 |
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ |
RECRUITING | PHASE1 |
| NCT06107673 |
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC） |
RECRUITING | PHASE2 |
| NCT06086340 |
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself. |
COMPLETED | |
| NCT05801705 |
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study |
UNKNOWN | |
| NCT05700006 |
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging |
COMPLETED | |
| NCT05361655 |
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor |
COMPLETED |
