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Key clinical point: Alisertib demonstrated clinically meaningful antitumor activity both with and without fulvestrant and a tolerable safety profile in patients with endocrine-resistant, human epidermal growth factor receptor 2-negative (ERBB2−) metastatic breast cancer (BC).
Major finding: The objective response rates were 19.6% (90% CI 10.6%-31.7%) and 20.0% (90% CI 10.9%-32.3%) for alisertib and alisertib+fulvestrant, respectively, and the median progression-free survival was approximately 5 months for both treatment arms. The most common grade ≥3 adverse events were neutropenia, leukopenia, and anemia.
Study details: Findings are from the phase 2 TBCRC041 trial including 91 patients with endocrine-resistant, ERBB2− metastatic BC who were previously treated with a cyclin-dependent kinase 4/6 inhibitor and were randomly assigned to receive alisertib alone or alisertib+fulvestrant.
Disclosures: This study was supported by Takeda Oncology. The authors declared receiving funding, fees, or research support or having other ties with several sources, including Takeda Oncology.
Source: Haddad TC et al. Evaluation of alisertib alone or combined with fulvestrant in patients with endocrine-resistant advanced breast cancer: The phase 2 TBCRC041 randomized clinical trial. JAMA Oncol. 2023 (Mar 9). Doi: 10.1001/jamaoncol.2022.7949
Key clinical point: Alisertib demonstrated clinically meaningful antitumor activity both with and without fulvestrant and a tolerable safety profile in patients with endocrine-resistant, human epidermal growth factor receptor 2-negative (ERBB2−) metastatic breast cancer (BC).
Major finding: The objective response rates were 19.6% (90% CI 10.6%-31.7%) and 20.0% (90% CI 10.9%-32.3%) for alisertib and alisertib+fulvestrant, respectively, and the median progression-free survival was approximately 5 months for both treatment arms. The most common grade ≥3 adverse events were neutropenia, leukopenia, and anemia.
Study details: Findings are from the phase 2 TBCRC041 trial including 91 patients with endocrine-resistant, ERBB2− metastatic BC who were previously treated with a cyclin-dependent kinase 4/6 inhibitor and were randomly assigned to receive alisertib alone or alisertib+fulvestrant.
Disclosures: This study was supported by Takeda Oncology. The authors declared receiving funding, fees, or research support or having other ties with several sources, including Takeda Oncology.
Source: Haddad TC et al. Evaluation of alisertib alone or combined with fulvestrant in patients with endocrine-resistant advanced breast cancer: The phase 2 TBCRC041 randomized clinical trial. JAMA Oncol. 2023 (Mar 9). Doi: 10.1001/jamaoncol.2022.7949
Key clinical point: Alisertib demonstrated clinically meaningful antitumor activity both with and without fulvestrant and a tolerable safety profile in patients with endocrine-resistant, human epidermal growth factor receptor 2-negative (ERBB2−) metastatic breast cancer (BC).
Major finding: The objective response rates were 19.6% (90% CI 10.6%-31.7%) and 20.0% (90% CI 10.9%-32.3%) for alisertib and alisertib+fulvestrant, respectively, and the median progression-free survival was approximately 5 months for both treatment arms. The most common grade ≥3 adverse events were neutropenia, leukopenia, and anemia.
Study details: Findings are from the phase 2 TBCRC041 trial including 91 patients with endocrine-resistant, ERBB2− metastatic BC who were previously treated with a cyclin-dependent kinase 4/6 inhibitor and were randomly assigned to receive alisertib alone or alisertib+fulvestrant.
Disclosures: This study was supported by Takeda Oncology. The authors declared receiving funding, fees, or research support or having other ties with several sources, including Takeda Oncology.
Source: Haddad TC et al. Evaluation of alisertib alone or combined with fulvestrant in patients with endocrine-resistant advanced breast cancer: The phase 2 TBCRC041 randomized clinical trial. JAMA Oncol. 2023 (Mar 9). Doi: 10.1001/jamaoncol.2022.7949