Parexel International ((PRXL)) announced an update on their ongoing clinical study.
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Study Overview: The study titled ‘A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma’ aims to provide access to tucatinib in the United States before FDA approval. This study is significant as it targets patients with HER2+ breast cancer, a challenging condition to treat, especially in advanced stages.
Intervention/Treatment: The study tests a combination of three drugs: Tucatinib, Capecitabine, and Trastuzumab. Tucatinib is administered orally at 300 mg twice daily, Capecitabine at 1000 mg/m² orally twice daily on Days 1-14 of each 21-day cycle, and Trastuzumab intravenously with a loading dose of 8 mg/kg followed by 6 mg/kg once per 21-day cycle. These drugs aim to manage and treat HER2+ breast cancer effectively.
Study Design: This is an expanded access study, meaning it provides patients with access to the treatment outside of a clinical trial setting. The study is open-label, indicating that both researchers and participants know which treatment is being administered. The primary purpose is to offer treatment access before FDA approval.
Study Timeline: The study was first submitted on January 3, 2020, with the latest update on June 23, 2025. These dates are crucial as they reflect the study’s progress and ongoing nature, indicating that the treatment is still under evaluation for broader use.
Market Implications: The update from this study could positively impact the stock performance of Seagen, a subsidiary of Pfizer, by enhancing investor sentiment due to the potential of tucatinib in treating advanced HER2+ breast cancer. This development may also influence the competitive landscape, as other companies in the oncology sector monitor the outcomes closely.
The study is ongoing, and further details are available on the ClinicalTrials portal.