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.
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
HRP-Fusion improved pCR prediction in HER2-positive breast cancer at ESMO TAT Asia 2026; experts also reviewed emerging endometrial targets and equitable access to HER2 therapies.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07768358 |
Tucatinib Continuation Study |
NOT_YET_RECRUITING | PHASE4 |
| NCT07748260 |
De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast |
NOT_YET_RECRUITING | PHASE3 |
| NCT07726342 |
SMP-656 for HER2-Positive Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07716046 |
Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07708194 |
Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure |
RECRUITING | PHASE1/PHASE2 |
| NCT07673029 |
A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer |
RECRUITING | PHASE3 |
| NCT07647263 |
Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer |
RECRUITING | PHASE2 |
| NCT07635342 |
Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer |
RECRUITING | PHASE2 |
| NCT07616440 |
Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer |
RECRUITING | NA |
| NCT07589699 |
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP |
NOT_YET_RECRUITING | PHASE4 |
