FDA Lifts Hold on Trial Investigating Novel Drug in Patients With High-Risk Breast Cancer

A clinical trial hold placed on a phase 3 study investigating the effects of a novel drug in patients with HER2/neu-positive primary breast cancer has been lifted by the Food and Drug Administration (FDA), according to a news release from the agent’s manufacturer, Greenwich LifeSciences Inc.

The FDA originally placed a hold on the trial because of the manufacturing and pharmaceutical process of the novel drug, known as GLSI-100.

Through discussions with the FDA and further testing of the pharmaceutical process of the drug, Greenwich LifeSciences noted that it had sufficiently addressed the issues that led to the hold. The release further stated that Greenwich LifeSciences has agreed to additional testing of the drug in its manufacturing process.

The randomized, multicenter study known as FLAMINGO-01, is expected to comprise approximately 600 adults with histologically confirmed diagnosis of HER2/neu-positive primary breast cancer.

The main goal of the study is to evaluate invasive breast cancer-free survival, which is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality. Of note, ipsilateral means that the disease is occurring on the same side of the body that the primary tumor was found.

Additional goals include reviewing invasive disease-free survival, distant disease-free survival (time from the first dose of study medication to the time of distant disease recurrence or death), overall survival (time from the first dose of study medication until death from any cause) and quality of life.

The expected completion of the trial is in December 2026.

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