Phase 2 Trial Investigating New Hormone-Based Drug for Breast Cancer

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Researchers are recruiting patients with ER-positive, HER2-negative breast cancer to participate in a trial evaluating (Z)-endoxifen.

The phase 2 EVANGELINE trial — which is evaluating the novel drug, (Z)-endoxifen in premenopausal patients with ER-positive, HER2-negatvie breast cancer — has officially kicked off, with the first patient being dosed, according to a press release from Atossa Therapeutics, the manufacturer of (Z)-endoxifen.

In particular, the trial is comparing outcomes in patients given presurgical (Z)-endoxifen plus the current standard of care, exemestane and gosereli, to those who received the standard of care only. The main outcome that researchers are looking for is endocrine sensitivity disease rate measured by Ki-67, a protein that may predict disease-free survival after four weeks of treatment.

Prior research has shown that patients treated with (Z)-endoxifen experienced, on average, a 65.1% decrease in Ki-67. Additionally, if given as a single-agent therapy, (Z)-endoxifen may eliminate the need for ovarian function suppression in this patient population.

“Approximately 78% of breast cancers are ER+ / HER2- and premenopausal women diagnosed with this disease need more effective and tolerable treatment options; specifically new treatments that do not require ovarian function suppression. We feel (Z)-endoxifen has the potential to change the treatment paradigm for these patients,” Dr. Steven Quay, president and chief executive officer at Atossa, said in a company-issued press release.

(Z)-endoxifen is a hormone-based treatment that blocks estrogen production and disrupts protein kinase C beta one (PRKCB1) function, which has been associated with the progression of multiple types of cancer.

Researchers are currently recruiting patients to participate in the trial, which will occur in cancer centers across the United States. They plan on enrolling approximately 174 patients with stage 2A or 2b invasive HER2-negative, ER-positive breast cancer. To be eligible for enrollment, patients must have their largest tumor be 2 cm or larger, and have little to no impact on their daily functioning due to their disease.

The study is expected to be complete in 2025.

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