Phase II Study of Adding Elacestrant to Olaparib for Adults With HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Having gBRCA12 Mutations

What this Trial Is About

Researchers are studying patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA12 mutations. This study aims to evaluate whether adding elacestrant, a new oral estrogen receptor blocker, to the standard olaparib treatment can improve progression-free survival compared to olaparib alone. This is a phase II, multi-center, randomized, open-label study with patients assigned in a 21 ratio to two different treatment groups. Participants randomized to Arm A will receive 600 mg of olaparib daily plus 400 mg of elacestrant daily, while those in Arm B will receive 600 mg of olaparib daily alone. Treatment will continue until disease progression, unacceptable side effects, patient withdrawal, or the study ends. Pre- and perimenopausal women, as well as men, will also receive a GnRH analogue at least two weeks before treatment starts. Dose modifications are provided for managing specific side effects. During the study, blood tests will be done at the start of each treatment cycle, and imaging scans along with quality of life assessments will be performed every three months or if disease progression is suspected. Researchers will measure progression-free survival, overall survival, treatment failure times, response rates, clinical benefit, adverse events, and treatment compliance. Participants may remain in the study for up to 48 months, with an average treatment duration of about 12 months per patient.

Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer