PURPOSE OF THE STUDY
The trial was designed to evaluate the safety and efficacy of adding Capivasertib to Taxol as first-line therapy for metastatic TNBC patients.
PATIENTS AND METHODS
A total of 140 patients were enrolled and randomized to two groups to received Taxol with either Capivasertib or Placebo. The primary goal of the study was the median time the disease has worsened. Secondary goals included survival and median time the disease has worsened and survival in the subgroup with PIK3CA/AKT1/PTEN alterations tumor and safety.
RESULTS
- In this randomized phase II trial, 140 women with metastatic triple-negative breast cancer, TNBC, received Taxol with either Capivasertib or Placebo as the first treatment.
- The median time the disease has worsened was 5.9 with Capivasertib-Taxol vs 4.2 months with Placebo-Taxol and median survival was 19.1 with Capivasertib-Taxol vs 12.6 months with Placebo-Taxol
- The median time the disease has worsened was more pronounced in patients with PIK3CA/AKT1/PTEN–altered tumors 9.3 months vs 3.7 months.
SAFETY
The most common adverse events in those treated with Capivasertib plus Taxol versus Placebo plus Taxol, respectively, were diarrhea, infection , neutropenia , rash and fatigue.
CONCLUSION
Addition of Capivasertib to first-line Taxol therapy for metastatic TNBC patients resulted in significantly longer time until disease worsening and longer survival. Benefits were more pronounced in patients with PIK3CA/AKT1/PTEN-altered tumors.
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