The phase 2 clinical study, ALISCATM-Breast1, recently started for patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer to evaluate treatment with alisertib.
A news release from Puma Biotechnology, the manufacturer of alisertib, announced the study’s initiation. The drug is an oral Aurora A kinase inhibitor, which helps prevent cancer cells from growing, as defined by the National Cancer Institute.
Researchers from the study are estimating to enroll a total of 150 patients and will randomly assign them to three treatment groups. Patients in these three groups will either receive alisertib at 50 milligrams (mg) group, alisertib at 40 mg or alisertib at 30 mg, respectively. Everyone in the study, regardless of treatment group, will also receive selected endocrine (hormone) therapy, according to the study’s listing on ClinicalTrials.gov.
Glossary
Objective response rate: percentage of patients who have a partial or complete response to treatment, meaning their tumors shrunk or disappeared after treatment.
Duration of response: time from patients’ start in a study until their cancer worsens or spreads, particularly among patients who showed partial or complete responses.
Disease control rate: percentage of patients who have a partial response, complete response or stable disease, meaning the status of their cancer has not worsened or improved.
Progression-free survival: time patients live without their disease worsening or spreading after receiving treatment.
Overall survival: time patients live, regardless of disease status, until death of any cause.
Specifically, patients in the trial receiving alisertib plus a selected endocrine therapy have HR-positive, HER2-negative recurrent or metastatic breast cancer. These eligible patients had previously received CDK 4/6 inhibitors and at least two lines of endocrine therapy within the recurrent or metastatic setting.
“Additional therapies are needed for patients with HER2-negative, HR-positive metastatic breast cancer whose disease progresses on CDK4/6 inhibitors in the first-line setting,” Dr. Joyce A. O’Shaughnessy, the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute in Dallas, Texas, said in the release. “The results from the TBCRC 041 trial indicated that alisertib has impressive clinical activity in the setting of endocrine therapy and CDK4/6 inhibitor-resistant metastatic breast cancer, with good tolerability. I look forward to the further evaluation of alisertib in the ALISCATM-Breast1 trial to definitively determine the clinical impact of this treatment.”
The purpose of the study is to determine the optimal dose of alisertib plus endocrine therapy, according to the release. The main goals of the study include objective response rate, duration of response, disease control rate, progression-free survival and overall survival.
The secondary goals of the study are to determine the same five aspects from the main goal but within subgroups focusing on biomarkers patients may have. Patients will provide blood and tissue specimens taken at the beginning of the study so researchers can analyze any potential biomarkers, according to the news release.
A meeting between Puma Biotechnology and the Food and Drug Administration (FDA) will be anticipated to discuss the potential approval of alisertib in HR-positive, HER2-negative metastatic breast cancer. After an optimal dose of alisertib with endocrine therapy is defined in this phase 2 study, researchers will plan for a phase 3 study, the release noted. The phase 3 study will aim to compare alisertib plus endocrine therapy chosen by researchers with placebo (inactive drug) plus endocrine therapy chosen by researchers.
“We are excited to initiate this phase 2 trial and to move forward with the development of alisertib in HER2-negative HR-positive metastatic breast cancer,” said Alan H. Auerback, chief executive officer, president and founder of Puma, in the release. “We believe that the data from the previous trial of alisertib monotherapy (published in the Lancet Oncology) as well as the TBCRC 041 trial (published in JAMA Oncology), which tested alisertib alone and with fulvestrant, and the randomized trial of alisertib plus paclitaxel versus paclitaxel alone (published in JAMA Network Open) have demonstrated that alisertib is active in patients with HER2-negative, HR-positive metastatic breast cancer and in biomarker-focused subgroups. We look forward to enrollment in the ALISCATM-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”
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