Breast Cancer Coverage from Every Angle

Ipatasertib Plus Paclitaxel in Triple-Negative Breast Cancer: Final Results of LOTUS Trial

By: Anna Nowogrodzki
Posted: Friday, July 24, 2020

Adding the oral AKT inhibitor ipatasertib to paclitaxel increased overall survival numerically but not significantly in patients with metastatic triple-negative breast cancer, according to the final results of the randomized phase II LOTUS trial. The results of the trial’s primary endpoint, progression-free survival, were previously reported, but the overall survival results were not mature at that time. Rebecca Dent, MD, of the National Cancer Centre Singapore, and colleagues published the final results in the Annals of Oncology.

“These findings support further evaluation of first-line ipatasertib plus paclitaxel for metastatic triple-negative breast cancer in the ongoing IPATunity130 randomized phase III trial,” the authors wrote. However, the study is limited by its small sample size.

The researchers treated 62 patients with paclitaxel plus ipatasertib and 62 patients with paclitaxel plus placebo. All patients had metastatic triple-negative breast cancer that had not been previously treated with systemic therapy. Patients received 80 mg/m2 of paclitaxel plus either a placebo or 400 mg of ipatasertib in 28-day cycles until disease progression or unacceptable toxicity. At the final cutoff date in September 2019, all patients had discontinued treatment, most because of disease progression.

In the intent-to-treat analysis, median overall survival was numerically longer but not significantly longer in patients who received paclitaxel plus ipatasertib (25.8 months, 95% confidence interval [CI] = 18.6–28.6 months) compared with those who received paclitaxel plus placebo (16.9 months, 95% CI = 14.6–24.6 months). The safety profile of paclitaxel plus ipatasertib was unchanged from previous reports.

Disclosure: The study authors’ disclosure information may be found at

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