The trial protocol is revised to enhance the evaluation of (Z)-endoxifen and abemaciclib in treating ER+/HER2- breast cancer. Credit: Gorodenkoff / Shutterstock.

Atossa Therapeutics has announced a protocol amendment in its ongoing clinical trial of (Z)-endoxifen along with Eli Lilly and Company’s abemaciclib in women with estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer.

The study is assessing the combination regimen as a neoadjuvant treatment in newly diagnosed ER+/HER2- breast cancer patients.

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The protocol changes involve an increase in the dose of (Z)-endoxifen from 40mg to 80mg once daily, based on safety, efficacy, and pharmacokinetic data from the Phase II EVANGELINE study.

The EVANGELINE study is targeting premenopausal women and has shown promising results with a significant reduction in the cellular proliferation marker Ki-67 and tumour size.

Data from the initial 40mg cohort of the EVANGELINE study indicated a 92% average reduction in Ki-67 and a 37% average decrease in target lesion size after a 24-week treatment period.

The trial has now progressed to an 80mg cohort, aiming to optimise drug concentrations for enhanced antitumor efficacy.

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In addition to the dose increase, the combination trial will now include around 80 participants across two cohorts, encompassing both pre- and menopausal women.

They will receive 80mg of (Z)-endoxifen daily plus 150mg abemaciclib twice a day for up to 24 weeks before the surgical procedure.

Ovarian function suppression will also be administered to premenopausal women in the second cohort.

The expansion in participant numbers is to ensure a statistically significant representation of both menopausal states.

The inclusion of ovarian function suppression is intended to facilitate a direct comparison between the two cohorts, potentially validating (Z)-endoxifen’s safety and effectiveness in premenopausal women without the need for OFS.

Under a clinical trial agreement, Atossa and Lilly are supplying their respective drugs for the study.

Atossa president and CEO Steven Quay  said: “We are extremely excited about the updated combination study protocol and grateful for the significantly expanded support from Eli Lilly to run the trial.

“As we expected, and the preliminary EVANGELINE data has confirmed, the 80 mg dose of (Z)-endoxifen has a highly favourable safety profile and delivers the desired concentration levels to optimally target PKCβ1.”