The ENDEAR (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of ENzalutamiDe in Combination With PaclitaxEl Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative BReast Cancer) trial will evaluate the efficacy and safety of enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic TNBC whose tumors test positive for a novel gene expression profile, which is referred to as diagnostic-positive TNBC.
The trial, which will be led by Medivation, is expected to begin patient enrollment in the fourth quarter of 2016.
In the United States, breast cancer is one of the most commonly diagnosed cancers and the second leading cause of cancer deaths in women. According to the American Cancer Society, approximately 246,000 new cases of breast cancer will be diagnosed in women and 40,000 women will die of breast cancer in 2016.1 Approximately 15-20 percent of breast cancers are triple negative or basal-like, the subtype that the ENDEAR trial will study.2 Patients with TNBC have a poor prognosis3 and there are currently no therapies specifically approved to treat this patient population.
"Our initiation of this trial represents our commitment to explore the potential of enzalutamide in patients with advanced TNBC," said Mohammad Hirmand, M.D., interim chief medical officer, Medivation.
"The initiation of the ENDEAR trial reflects our ongoing commitment to investigate the full clinical utility of enzalutamide," said Claire Thom, Pharm D., senior vice president and oncology therapeutic area head, Astellas.
Enzalutamide, which is known by the brand name XTANDI®, is not approved for use in patients with TNBC.
About ENDEAR
ENDEAR will be a Phase III, randomized, international trial, enrolling approximately 780 patients with advanced diagnostic-positive TNBC who have received either no or one prior line of systemic therapy for advanced disease.
The primary efficacy endpoint is progression-free survival (PFS), defined as the time from randomization to the first evidence of disease progression or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg per day taken orally, either with paclitaxel (90 mg/m2) administered intravenously once weekly for 16 weeks (or longer at investigator discretion), or as monotherapy compared to placebo with paclitaxel.
About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) capsules are an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors as well as inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.
XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).