Breast Cancer Coverage from Every Angle

Adding Oral Alisertib to Weekly Paclitaxel for Metastatic Breast Cancer

By: Noelle Cutter, PhD
Posted: Wednesday, May 26, 2021

A randomized phase II trial investigated the effect of adding the Aurora kinase A inhibitor alisertib to a reduced dose of weekly paclitaxel in the treatment of patients with estrogen receptor–positive, ERBB2-negative, or triple-negative metastatic breast cancer. According to Joyce O’Shaughnessy, MD, and researchers from Baylor University Medical Center, Dallas, the combination treatment significantly improved progression-free survival compared with paclitaxel alone. Their findings were published in JAMA Network Open.

“These findings suggest that in patients with estrogen receptor–positive, ERBB2-negative metastatic breast cancer, the addition of alisertib to paclitaxel is promising and worthy of further study,” the authors noted.

A total of 139 patients from the US Oncology Network were enrolled in this clinical trial. Patients received either intravenous paclitaxel at 90 mg/m2 on days 1, 8, and 15 of a 28-day cycle or intravenous paclitaxel at 60 mg/m2 on days 1, 8, and 15 plus oral alisertib at 40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle.

The results indicated that the median interquartile range (IQR) progression-free survival was 10.2 months (3.8–15.7 months) with paclitaxel plus alisertib and 7.1 months (3.8–10.6 months) with paclitaxel alone (hazard ratio [HR] = 0.56; 95% confidence interval [CI] = 0.37–0.84; P = .005). The median overall survival was 26.3 months (12.4–37.2 months) for the combination treatment versus 25.1 months (11.0–31.4 months) for paclitaxel alone (HR = 0.89; 95% CI = 0.58–1.38; P = .61). Adverse events were reported in 84.8% of patients given paclitaxel plus alisertib versus 48.6% of those given paclitaxel alone.

“Estrogen receptor–positive, ERBB2-negative metastatic breast cancer is a heterogeneous disease, and this study does not provide insight into how to identify patients who may benefit from adding alisertib to paclitaxel, as well as those who may not benefit,” the researchers cautioned, however.

Disclosure: For full disclosures of the study authors, visit

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