NCT06062498

Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.

Detailed description

Primary Objective I. Evaluate progression-free survival (PFS) of patients with advanced or metastatic ERpositive/HER2-negative breast cancer who have been treated with either elacestrant monotherapy or combination therapy of elacestrant with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib). PFS of the elacestrant monotherapy arm will be compared with PFS of the combination therapy arm. Secondary Objectives I. Assess toxicity profile of elacestrant combination therapy with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) in advanced or metastatic ER-positive/HER2- negative breast cancer according to NCI-CTCAE v5.0. II. Assess duration of response (DOR) in patients with advanced or metastatic ERpositive/HER2-negative breast cancer who have been treated with either elacestrant monotherapy or combination therapy of elacestrant with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib). DOR of the elacestrant monotherapy arm will be compared with DOR of the combination therapy arm. III. Determine overall survival (OS) in patients with advanced or metastatic ER-positive, HER2-negative breast cancer who have been treated with either elacestrant monotherapy or combination therapy of elacestrant with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib). OS of the elacestrant monotherapy arm will be compared with OS of the combination therapy arm. OUTLINE: Patients will receive either elacestrant monotherapy or combination therapy with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) orally for each 28 day cycle until progressive disease, unacceptable toxicity, treating physician decision, or patient withdrawal of consent. Patients will be followed (either by routine clinic visit or by phone call) every 36 weeks for 2 years and then every 72 weeks up to 5 years total from time of registration to document survival and disease progression.

Conditions

• Estrogen-receptor-positive Breast Cancer
• HER2/Neu-Negative Breast Cancer
• Advanced Breast Cancerv
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	elacestrant, palbociclib, abemaciclib, ribociclib	Given orally

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2023-10-02
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study