Perjeta is the brand name for pertuzumab, a humanized monoclonal antibody used in HER2-positive breast cancer treatment. It is commonly used in combination with trastuzumab and chemotherapy in metastatic and early-stage settings. The FDA first approved Perjeta on June 8, 2012.
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.
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.
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.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
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.
Innovent Biologics has dosed the first participant in its pivotal Phase 3 HeriCare-Breast01 study evaluating IBI354, a HER2-targeted antibody-drug conjugate, as first-line treatment for unresectable locally advanced or metastatic HER2-positive breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07578116 |
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07565324 |
Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07545044 |
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07528898 |
Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07527806 |
Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging |
NOT_YET_RECRUITING | PHASE2 |
| 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 |
| NCT07470203 |
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer |
NOT_YET_RECRUITING | |
| NCT07441460 |
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer |
RECRUITING | PHASE3 |
| NCT07421141 |
De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07407920 |
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial |
ACTIVE_NOT_RECRUITING | PHASE2 |
