HER2-positive breast cancer is a breast cancer subtype characterized by HER2 overexpression or amplification. It tends to grow and spread faster than HER2-negative disease but is responsive to HER2-targeted therapies. Accurate receptor testing is essential for treatment selection.
Puma Biotechnology reported quarterly revenue of $75.50 million and EPS of $0.26, above consensus estimates. The company also guided for 2026 total revenue of US$214 million to US$221 million and net income of US$10 million to US$13 million.
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
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.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
New clinical trial data show trastuzumab deruxtecan plus pertuzumab extends progression-free survival as first-line therapy, while MRI-guided treatment shortening reduces toxicity in neoadjuvant settings for HER2-positive breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07589699 |
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP |
NOT_YET_RECRUITING | PHASE4 |
| NCT07518173 |
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07510802 |
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC |
RECRUITING | PHASE1/PHASE2 |
| NCT07486089 |
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) |
RECRUITING | PHASE1/PHASE2 |
| NCT07470203 |
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer |
NOT_YET_RECRUITING | |
| NCT07459673 |
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission |
RECRUITING | PHASE2 |
| NCT07454668 |
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07421141 |
De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07417241 |
SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study |
NOT_YET_RECRUITING | PHASE2 |
| NCT07416409 |
Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer |
COMPLETED |
