AstraZeneca ((AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc ((GB:AZN)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
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AstraZeneca’s ongoing Phase III clinical trial, titled ‘A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study,’ aims to evaluate the effectiveness of AZD9833 in combination with CDK4/6 inhibitors compared to traditional aromatase inhibitors in treating HR-positive, HER2-negative metastatic breast cancer with detectable ESR1 mutations.
The study is testing AZD9833, a next-generation oral selective estrogen receptor degrader (SERD), in combination with CDK4/6 inhibitors such as palbociclib, abemaciclib, or ribociclib. This combination is intended to improve treatment outcomes for patients with specific genetic mutations that reduce the efficacy of existing therapies.
This interventional study employs a randomized, parallel assignment model with triple masking (participant, care provider, investigator) to ensure unbiased results. The primary purpose is treatment-focused, aiming to determine the superiority of AZD9833 over current standard therapies.
The study began on June 30, 2021, and is currently active but not recruiting. The last update was submitted on July 15, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
The outcome of this study could significantly impact AstraZeneca’s market position, potentially boosting its stock if AZD9833 proves more effective than existing treatments. This could also influence investor sentiment positively, especially if the drug addresses unmet needs in breast cancer treatment. Competitors in the oncology space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.