Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Starting soon Phase 2

ADC Based Therapy Accroding to HER2 Heterogeneous

NCT07844018 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2027-01-01
Last updated
2026-10-02

Condition(s) studied

Breast Cancer (Early Breast Cancer)

Investigational drug(s) / intervention(s)

HER2 target therapy

HER2 target therapy: Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy.

Study summary

This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity/heterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1.18 years or older and be treatment-naïve breast cancer patients 2.histology confirmed invasive breast carcinoma.HER2-positive defined by our pathology department, defined as IHC 3+ or IHC 2+ with fluorescence/chromogenic in situ hybridization (FISH/CISH) confirming HER2 gene amplification; 3.Clinically staged as Stage II or III according to AJCC 8th edition 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5.Adequate function of major organs to meet study safety and tolerability requirements 6.Agree to provide tissue biopsies and/or blood samples at specified study timepoints (baseline, after cycle 4, after cycle 8, and at surgical resection) for translational research purposes 7.No contraindication to breast-enhanced MRI (no contraindications to breast MRI enhancement 8.Reproductive-age women must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception recognized clinically during the study and for 3 months after the last study drug administration 9.agrees to participate in this study and signs the informed consent form Exclusion Criteria: * 1.bilateral breast cancer or presenting as recurrent or metastatic disease 2.Within the preceding 5 years prior to written informed consent, any history of malignant neoplasm other than treated cervical in situ carcinoma, skin basal cell carcinoma, or skin squamous cell carcinoma will exclude the subject 3.Within 4 weeks prior to enrollment, subjects who have undergone major surgery unrelated to breast cancer, or who have not fully recovered from such surgery, are excluded; procedures necessary for diagnostic tissue biopsy or peripheral venous catheter placement are allowed 4.History of interstitial lung disease (ILD) or non-infectious pneumonia, or current active ILD/pneumonia, or radiologic findings during screening that cannot exclude suspected ILD/pneumonia 5.Presence of significant cardiac disease or other conditions that would make participation unsafe or unsuitable 6.Severe infection within 4 weeks prior to the first dose 7.Known HIV infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV-DNA ≥ 500 IU/mL) or hepatitis C (HCV-RNA above the assay's lower limit) or co-infection with HBV and HCV; autoimmune hepatitis 8.Known hypersensitivity to the study drug or any of its excipients 9.Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women unwilling to use an effective contraception method throughout the study 10.History of definite neurologic or psychiatric disorders including epilepsy or dementia, or known history of psychiatric drug abuse, alcoholism, or substance misuse 11.Any other condition that, in the opinion of the investigator, would make participation unsuitable for this study.

Primary outcome measure(s)

  • pathology complete response rate — From enrollment to the end of treatment at 6 months
    After completing neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained samples from the resected breast cancer tissue and all ipsilateral lymph node specimens shows no residual invasive carcinoma.

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07844018 on ClinicalTrials.gov ↗ ← All trials in China