A recent multicenter phase II study has delivered promising final overall survival data for CR1447, a transdermal formulation targeting metastatic breast cancer. The trial focused on patients with specific breast cancer subtypes and evaluated the drug’s efficacy and safety as a treatment option.
Study Design and Patient Selection
The investigation included two cohorts: cohort A comprised 29 patients with estrogen receptor-positive, HER2-negative metastatic breast cancer who had undergone up to one prior endocrine therapy without disease progression for at least six months. Cohort B involved eight patients with androgen receptor-positive triple-negative metastatic breast cancer, each having received up to two prior chemotherapy treatments. The study aimed to assess the disease control rate at the 24-week mark, ultimately ceasing enrollment in 2018 due to lack of sufficient efficacy in cohort A and slow recruitment in cohort B.
Key Findings and Safety Profile
By the data cut-off, 92% of participants had deceased. Cohort A’s median overall survival reached 35.4 months in the intention-to-treat population, contrasting with 19.4 months in the non-intention-to-treat group. Cohort B saw a median survival of 10.8 months. The treatment regimen was generally well-tolerated, with most adverse effects being mild to moderate, including hypertriglyceridemia, elevated aspartate aminotransferase levels, and dry skin.
– CR1447 demonstrates comparable overall survival rates to existing endocrine therapies in specific breast cancer populations.
– The drug’s favorable safety profile underscores its potential as a viable treatment option.
– Limited efficacy observed in certain cohorts suggests the need for targeted patient selection.
CR1447 emerges as a noteworthy addition to the therapeutic landscape for metastatic ER-positive, HER2-negative breast cancer. Its administration via a transdermal route simplifies treatment protocols and enhances patient compliance. Researchers highlight the importance of identifying suitable patient subgroups to maximize therapeutic benefits. Future studies might explore combination therapies to further improve outcomes and expand the drug’s applicability across different cancer profiles.
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