AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
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AstraZeneca has initiated a Phase 4 clinical study titled ‘A Prospective, Multi-Center Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, an Anti-HER2-Antibody Drug Conjugate in Indian Patients With Unresectable or Metastatic HER2-Positive Breast Cancer Who Have Received a Prior Anti-HER2-Based Regimen.’ The study aims to evaluate the safety of Trastuzumab Deruxtecan in Indian patients, providing crucial data on its safety profile in this demographic.
The study tests Trastuzumab Deruxtecan, a drug designed to treat HER2-positive breast cancer. Administered via IV infusion, it is given at 5.4 mg/kg on day 1 of a 21-day cycle for nine cycles.
This interventional study follows a single-group assignment model without masking, focusing primarily on treatment. It is designed to gather safety data in a real-world setting.
The study began on January 2, 2025, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on June 27, 2025, indicating ongoing recruitment.
This study could influence AstraZeneca’s stock performance by potentially expanding the market for Trastuzumab Deruxtecan in India, enhancing investor sentiment. The study’s progress may also impact competitors focusing on similar treatments.
The study is ongoing, with further details available on the ClinicalTrials portal.